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Exhibit 10.4

CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT OF 1933.

PATENT AND TECHNOLOGY LICENSE AGREEMENT

This AGREEMENT (“AGREEMENT”) is made on this 14th day of December, 2010, by and between THE BOARD OF REGENTS (“BOARD”) of THE UNIVERSITY OF TEXAS SYSTEM (“SYSTEM”), an agency of the State of Texas, whose address is 201 West 7th Street, Austin, Texas 78701, on behalf of THE UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER (“UTMDACC”), a member institution of SYSTEM, and ARROWHEAD RESEARCH CORPORATION a Delaware corporation having a principal place of business located at 201 South Lake Avenue, Suite 703, Pasadena, CA 91101 (“LICENSEE”).

RECITALS

 

A.

BOARD owns certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to LICENSED SUBJECT MATTER developed at UTMDACC.

 

B.

BOARD, through UTMDACC, desires to have the LICENSED SUBJECT MATTER developed in the LICENSED FIELD and used for the benefit of LICENSEE, BOARD, SYSTEM, UTMDACC, the inventor(s), and the public as outlined in BOARD’s Intellectual Property Policy.

 

C.

LICENSEE wishes to obtain a license from BOARD to practice LICENSED SUBJECT MATTER.

NOW, THEREFORE, in consideration of the mutual covenants and promises herein contained, the parties agree as follows:

I. EFFECTIVE DATE

 

1.1

This AGREEMENT is effective as of the date written above (“EFFECTIVE DATE”) which is the date fully executed by all parties.

 

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II. DEFINITIONS

As used in this AGREEMENT, the following terms have the meanings indicated:

 

2.1

AFFILIATE means any business entity more than fifty percent (50%) owned by LICENSEE, any business entity which owns more than fifty percent (50%) of LICENSEE, or any business entity that is more than fifty percent (50%) owned by a business entity that owns more than fifty percent (50%) of LICENSEE.

 

2.2

IMPROVEMENT (s) means BOARD’s rights in any invention that is an improvement or modification to the PATENT RIGHTS in the LICENSED FIELD, that cannot be practiced without infringing a claim of any issued patent or pending application under the PATENT RIGHTS, and that:

 

 

(1)

is conceived and reduced to practice solely by Wadih Arap, M.D., Ph.D. and/or Renata Pasqualini, Ph.D., and/or any UTMDACC lab personnel working solely under the supervision of either of them, while both are employed solely by UTMDACC, and is conceived and reduced to practice solely at UTMDACC-owned facilities; and

 

 

(2)

is conceived and reduced to practice within five (5) years of the EFFECTIVE DATE; and

 

 

(3)

is not obligated, in whole or in part, to a third party in any field of use and is owned solely by the BOARD; and

 

 

(4)

is disclosed to UTMDACC’s Office of Technology Commercialization “OTC”) in accordance with UTMDACC’s Intellectual Property Policy or is otherwise disclosed to OTC.

 

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Notwithstanding the foregoing, IMPROVEMENTS shall not include any improvement or modification involving or related to the EXCLUDED PEPTIDES/FRAGMENTS.

 

2.3

IND means the application submitted to the United States Food and Drug Administration (“FDA”) for approval to conduct a clinical investigation with an investigational new drug, as more specifically defined by 21 C.F.R. §312 et seq., or any future revisions or substitutes thereof, or an equivalent application filed with any equivalent regulatory agency or governmental authority in any jurisdiction other than the United States.

 

2.4

LICENSED FIELD means the fields of: (A) therapeutics, diagnostics and research products and services that satisfy both of the following criteria: (1) the products and services incorporate peptides that specifically target receptors on adipose tissue or vasculature associated with adipose tissue; and (2) the products and services are used to treat, diagnose or research solely the following: (a) obesity and overweight; and/or (b) metabolic conditions related to, caused by, and/or associated with obesity and overweight; and (B) cancer therapeutics, cancer diagnostics and cancer research products and services, involving the direct or indirect use of any of the *** peptide, any functional fragments thereof, or any derivatives or functional analogs of any such peptides or fragments. Notwithstanding the foregoing, the LICENSED FIELD shall not include any field that involves the direct or indirect use of any of the following peptides, any functional fragments thereof, or any derivatives, or analogs of any such peptides or fragments (including any compositions, products, processes,

 

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methods, or services comprising or incorporating any of the foregoing peptides, fragments, derivatives or analogs (collectively, the ***): (1) the ***; (2) the ***; (3) the ***; (4) the ***; (5) the ***; and (6) the ***.

 

2.5

LICENSED PRODUCTS means any product or service sold by LICENSEE or its AFFILIATES or their sublicensees comprising LICENSED SUBJECT MATTER pursuant to this AGREEMENT.

 

2.6

LICENSED SUBJECT MATTER means inventions and discoveries covered by PATENT RIGHTS or TECHNOLOGY RIGHTS within LICENSED FIELD.

 

2.7

LICENSED TERRITORY means worldwide.

 

2.8

MARKETING APPROVAL means the approval required by the United States Food and Drug Administration (“FDA”) in the United States, or an equivalent regulatory agency or governmental authority in any jurisdiction other than the United States, to market and sell a LICENSED PRODUCT in such jurisdiction.

 

2.9

NDA means a New Drug Application or Biologics License Application filed with the FDA in connection with obtaining MARKETING APPROVAL, or an equivalent application filed with any equivalent regulatory agency or governmental authority in any jurisdiction other than the United States.

 

2.10

NET SALES means the gross revenues received by LICENSEE or its AFFILIATES or their sublicensees from a SALE less sales discounts actually granted, sales and/or use taxes actually paid, import and/or export duties actually

 

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paid, outbound transportation actually prepaid or allowed, and amounts actually allowed or credited due to returns (not exceeding the original billing or invoice amount), all as recorded by LICENSEE or its AFFILIATES or their sublicensees in their official books and records in accordance with generally accepted accounting practices and consistent with their published financial statements and/or regulatory filings with the United States Securities and Exchange Commission.

 

2.11

PATENT RIGHTS means BOARD’s rights in the information or discoveries described in invention disclosures, or claimed in any patents and/or patent applications, whether domestic or foreign, as identified in Exhibit I attached hereto, and all divisionals, continuations, continuations-in-part (to the extent the claims of such continuations-in-part are entitled to claim priority to the aforesaid patents and/or patent applications identified in Exhibit I), reissues, reexaminations or extensions of the patents and/or patent applications identified in Exhibit I, and any letters patent, domestic or foreign, that issue thereon.

 

2.12

PHASE I CLINICAL STUDY means: (a) that portion of the FDA submission and approval process which provides for the first introduction into humans of a product with the purpose of determining human toxicity, metabolism, absorption, elimination and other pharmacological action, as more fully defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(a) or any future revisions or substitutes therefor; or (b) a similar clinical study in any jurisdiction other than the United States.

 

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2.13

PHASE II CLINICAL STUDY means: (a) that portion of the FDA submission and approval process which provides for early controlled clinical studies conducted to obtain preliminary data on the effectiveness of a product for a particular indication, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(b) or any future revisions or substitutes therefor; or (b) a similar clinical study in any jurisdiction other than the United States.

 

2.14

PHASE III CLINICAL STUDY means: (a) that portion of the FDA submission and approval process in which expanded clinical trials are conducted to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of a product, as more specifically defined by the rules and regulations of the FDA, including 21 C.F.R. § 312.21(c) or any future revisions or substitutes therefor; or (b) a similar clinical study in any jurisdiction other than the United States.

 

2.15

SALE or SOLD means the transfer or disposition of a LICENSED PRODUCT for value to a party other than LICENSEE, an AFFILIATE or a ROYALTY-FREE PRACTITIONER. As used herein, “ROYALTY-FREE PRACTITIONER” means UTMDACC and the following individuals: Wadih Arap, M.D., Ph.D. and Amado Zurita-Saavedra, M.D. (“PHYSICIAN INVENTORS”), and any partner or associate who practices medicine with one or more of the PHYSICIAN INVENTORS, but with respect to such partner or associate, only for such time as he/she is engaged in a bona fide medical practice with one or more of the PHYSICIAN INVENTORS.

 

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2.16

TECHNOLOGY RIGHTS means BOARD’s rights in any technical information, know-how, processes, procedures, compositions, devices, methods, formulae, protocols, techniques, software, designs, drawings or data created by the inventor(s) listed in Exhibit I at UTMDACC before the EFFECTIVE DATE, which are not claimed in PATENT RIGHTS but that are necessary for practicing PATENT RIGHTS.

 

2.17

VALID CLAIM means: (a) a claim of any issued, unexpired patent that has not been revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and that has not been disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise; or (b) a claim of any pending or published patent application that that has not been cancelled, withdrawn or abandoned and that has not been pending for more than five (5) years from the filing date of the earliest patent application from which the pending or published application containing such claim claims priority. For purposes of clarification, if a claim in an application has been pending for more than five (5) years from its priority date, and a patent subsequently issues containing such claim, then upon issuance of the patent, the claim shall thereafter be considered a VALID CLAIM.

 

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III. LICENSE

 

3.1

BOARD, through UTMDACC, hereby grants to LICENSEE a royalty-bearing, exclusive license under LICENSED SUBJECT MATTER to manufacture, have manufactured, use, import, offer to sell and/or sell LICENSED PRODUCTS within LICENSED TERRITORY for use within LICENSED FIELD. This grant is subject to Sections 14.1, 14.2 and 14.3 hereinbelow, the payment by LICENSEE to UTMDACC of all consideration as provided herein, the timely payment of all amounts due hereunder, and is further subject to the following rights retained by BOARD and UTMDACC to:

 

 

(a)

Publish the general scientific findings from research related to LICENSED SUBJECT MATTER, subject to the terms of ARTICLE XI–Confidential Information and Publication; and

 

 

(b)

Use LICENSED SUBJECT MATTER for: (1) commercial and non-commercial research; and (2) teaching, patient care, and other academically-related purposes; provided however, that BOARD and UTMDACC shall not engage in commercial research that is specifically directed to the use of PATENT RIGHTS and/or TECHNOLOGY RIGHTS in the LICENSED FIELD. BOARD and UTMDACC may engage in general commercial research with respect to PATENT RIGHTS and TECHNOLOGY RIGHTS and in commercial research in fields of use other than the LICENSED FIELD.

 

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3.2

LICENSEE may extend the license granted herein to any AFFILIATE provided that the AFFILIATE consents in writing to be bound by this AGREEMENT to the same extent as LICENSEE. LICENSEE agrees to deliver such contract to UTMDACC within thirty (30) calendar days following execution thereof.

 

3.3

LICENSEE may grant sublicenses under LICENSED SUBJECT MATTER consistent with the terms of this AGREEMENT provided that LICENSEE is responsible for its sublicensees relevant to this AGREEMENT, and for diligently collecting all amounts due LICENSEE from sublicensees. If a sublicensee pursuant hereto becomes bankrupt, insolvent or is placed in the hands of a receiver or trustee, LICENSEE, to the extent allowed under applicable law and in a timely manner, agrees to use its best commercially reasonable efforts to collect all consideration owed to LICENSEE and to have the sublicense agreement confirmed or rejected by a court of proper jurisdiction.

 

3.4

LICENSEE must deliver to UTMDACC a true and correct copy of each sublicense granted by LICENSEE, and any modification or termination thereof, within sixty (60) calendar days after execution, modification, or termination.

 

3.5

If this AGREEMENT is terminated pursuant to ARTICLE XIII-Term and Termination, BOARD and UTMDACC agree to accept as successors to LICENSEE, existing sublicensees in good standing at the date of termination provided that each such sublicensee consents in writing to be bound by all of the terms and conditions of this AGREEMENT.

 

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3.6

UTMDACC shall promptly disclose any IMPROVEMENTS to LICENSEE. LICENSEE shall have ninety (90) days from the date of such disclosure to notify UTMDACC in writing whether LICENSEE desires to include such IMPROVEMENTS under this AGREEMENT. If LICENSEE desires to include a disclosed IMPROVEMENT in this AGREEMENT, the parties shall enter into an amendment to this AGREEMENT adding BOARD’s rights in such IMPROVEMENT to Exhibit I, giving LICENSEE a license to such IMPROVEMENT in the LICENSED FIELD. LICENSEE will reimburse UTMDACC for all documented legal and filing fees incurred by UTMDACC relating to any IMPROVEMENT added to this AGREEMENT. If LICENSEE does not send written notice to UTMDACC of its desire to add the IMPROVEMENT to the AGREEMENT prior to expiration of the ninety (90) day period, then thereafter UTMDACC shall have the right to freely license the IMPROVEMENT to third parties, with no further obligation or consideration due to LICENSEE. In the event an IMPROVEMENT is added to the AGREEMENT pursuant to this Section 3.6, the term “EFFECTIVE DATE” as used in Section 2.16 for purposes of defining the TECHNOLOGY RIGHTS related to such IMPROVEMENT shall be deemed to be the effective date of the amendment adding such IMPROVEMENT to this AGREEMENT.

 

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IV. CONSIDERATION, PAYMENTS AND REPORTS

 

4.1

In consideration of rights granted by BOARD to LICENSEE under this AGREEMENT, LICENSEE agrees to pay UTMDACC the following:

 

 

(a)

All documented legal and filing fees incurred by UTMDACC after the EFFECTIVE DATE in filing, prosecuting, and maintaining PATENT RIGHTS, and all such future expenses incurred by UTMDACC, for so long as, and in such countries as this AGREEMENT remains in effect (“PATENT EXPENSES”). Notwithstanding the foregoing, in the event that there are other entities with licenses to both of the technologies listed on Exhibit I in other fields of use (“ADDITIONAL LICENSEES”), then LICENSEE shall be obligated to pay only a pro rata share of the PATENT EXPENSES as follows. LICENSEE’s pro rata share shall be


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