Back to top

PHENYLBUTYRATE CO-DEVELOPMENT AND SUBLICENSE AGREEMENT

Development Agreement

PHENYLBUTYRATE CO-DEVELOPMENT AND SUBLICENSE AGREEMENT | Document Parties: SOMANTA PHARMACEUTICALS INC. | BRIDGE THERAPEUTIC PRODUCTS INC | BRIDGE  ONCOLOGY PRODUCTS INC. You are currently viewing:
This Development Agreement involves

SOMANTA PHARMACEUTICALS INC. | BRIDGE THERAPEUTIC PRODUCTS INC | BRIDGE ONCOLOGY PRODUCTS INC.

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: PHENYLBUTYRATE CO-DEVELOPMENT AND SUBLICENSE AGREEMENT
Governing Law: New York     Date: 7/19/2006

PHENYLBUTYRATE CO-DEVELOPMENT AND SUBLICENSE AGREEMENT, Parties: somanta pharmaceuticals inc. , bridge therapeutic products inc , bridge  oncology products inc.
50 of the Top 250 law firms use our Products every day

 

 

 

CONFIDENTIAL TREATMENT REQUESTED

  

EXHIBIT 10.10

CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 406 THE SECURITIES ACT OF 1933 CONFIDENTIAL TREATMENT IS REQUESTED AND IS NOTED WITH “[CONFIDENTIAL TREATMENT REQUESTED].” AN UNREDACTED VERSION OF THIS DOCUMENT HAS BEEN PREVIOUSLY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.

P HENYLBUTYRATE C O -D EVELOPMENT AND

S UBLICENSE A GREEMENT

BY AND AMONG

B RIDGE T HERAPEUTIC P RODUCTS , I NC AND

B RIDGE O NCOLOGY P RODUCTS , I NC .


CONFIDENTIAL TREATMENT REQUESTED

 

PHENYLBUTYRATE CO-DEVELOPMENT AND SUBLICENSE

AGREEMENT

BY AND BETWEEN

BRIDGE THERAPEUTIC PRODUCTS INC. AND BRIDGE

ONCOLOGY PRODUCTS INC.

DATED AND EFFECTIVE: FEBRUARY 16, 2005


CONFIDENTIAL TREATMENT REQUESTED

 

Strictly Confidential

SUBLICENSE AGREEMENT

THIS AGREEMENT (the “Agreement”), is made and effective as of February 16, 2005 (the “Effective Date”), by and between Bridge Therapeutic Products Inc. (“BTP”) and Bridge Oncology Products Inc. (“BOP” and, together with BTP, the “Parties”).

RECITALS:

WHEREAS BTP, Inc. (“BTP”) has worldwide rights to intellectual property, commercialization rights and know how pertaining to phenylbutyrate (“PB” or the “PB Technology”), and

WHEREAS Bridge Oncology Inc. (“BOP”) wishes to enter into an exclusive sublicense to all of BTP’s PB Technology in the Territory (defined as worldwide with the exception of the United States of America and Canada), including, without limitation, any and all patents, patent applications, continuations, continuations-in-part, inventions, improvements, know how, trademarks, trade secrets, and any and all other intellectual property or proprietary information related thereto, in each case, together with any and all commercialization rights pertaining to the PB technology (collectively, the “Sublicensed Technology”).

NOW, THEREFORE, in consideration of the mutual premises, covenants and agreements set forth in this Sublicense Agreement, and other good and valuable consideration the receipt and sufficiency of which is hereby acknowledged, BTP and BOP hereby agree as follows:

 

1.

Grant of Sublicense

 

 

1.1

The intention and purpose of the Sublicense Agreement is to continue to promote the on-going development programs already instituted by BTP and outside clinical investigators for PB, to maximize the potential therapeutic benefit of PB for the treatment of certain cancers, autoimmune diseases and other clinical indications, and to expedite a global strategy for the development, regulatory approval and commercial development of PB.

 

 

1.2

BTP hereby grants to BOP an exclusive sub-license to all of BTP’s intellectual property rights, including without limitation, any and all patents, patent applications, continuations, continuations-in-part, inventions, improvements, trademarks, trade secrets, and any and all other intellectual property or proprietary information related thereto, in each case, together with any and all commercialization rights and all know how to PB (collectively, the “Sublicense”) in the Territory (defined as worldwide with the exception of the United States of America and Canada). For purposes of this Sublicense Agreement, the parties hereto acknowledge and agree that the Sublicense shall include, without limitation, all rights, title and interest to the Public Health Service Patent License Agreement, dated May 25, 1995, between the Public Health Service and the National Institute of Health and BTP, in the form attached as Exhibit 1 hereto (the


CONFIDENTIAL TREATMENT REQUESTED

 

 

“PHSP License Agreement”), together with all rights, title and interests conveyed thereunder.

 

2.

Consideration

 

 

2.1

In consideration of the Sublicensed Technology, BOP agrees to pay BTP US$50,000.00 as soon as commercially reasonable after the Effective Date.

 

 

2.2

BOP will pay royalties to BTP on all direct sales of PB or any product incorporating the PB Technology within the Territory of [CONFIDENTIAL TREATMENT REQUESTED] . In any country with the Territory where PB or any product incorporating the PB Technology is sold by a third party, such as distributor, wholesaler or marketing company, any payments made by their third party as part of the acquisition of rights to sell or distribute PB or any product incorporating the PB Technology shall be shared equally between BOP and BTP.

 

 

2.3

BOP agrees to pay all costs and expenses of prosecuting, filing and maintaining Patents and defending revocation proceedings on patent and patent applications on PB in all other countries within the Territory (which specifically excludes the United States of America and Canada).

 

3.

Co-Development Plan

 

 

3.1

The parties to this Agreement hereby agree to cooperate in the development and commercialization of PB. BTP will be responsible for conducting all clinical trials and the filing and prosecution of all applications with applicable USA and Canadian regulatory authorities, and all regulatory filings in the USA and Canada will be in the name of BTP. BOP will be responsible for conducting all clinical trials and the filing and prosecution of all applications with applicable regulatory authorities other than in the USA and Canada and all such filings shall be in the name of BOP.

 

 

3.2

The parties will promptly share all information generated under this co-development program pursuant to confidentiality including, without limitation, all information with respect to market analysis, competitor position, pre-clinical and clinical trials, the filing of any applications with the US Food and Drug Administration or similar Canadian authority and the manufacture and testing of different formulations and preparations of PB or any product incorporating the PB Technology.

 

 

3.3

BTP shall pay all costs and expenses of any work deemed necessary for the development of PB in the USA and Canada. BOP shall pay all costs and expenses of any work deemed necessary for the development of PB in any other countries within the Territory (other than USA or Canada).

 

2


CONFIDENTIAL TREATMENT REQUESTED

 

4.

Representations and Warranties

 

 

4.1

The parties agree that this Agreement shall constitute a binding and enforceable agreement between the parties. In this regard, the parties agree to use commercially reasonable efforts to work together in good faith to obtain all necessary consents and approvals required from the National Institute of Health’s Public Health Service and any other third party or governmental authority reasonably required to provide a consent, if any, as soon as reasonably practicable after the date hereof.

 

 

4.2

BTP hereby represents, warrants and covenants to BOP that BTP has full right, power and authority to enter into this Agreement.

 

 

4.3

BOP represents that it has full power, authority to enter into this Agreement.

 

 

4.4

BTP is unaware of any claims asserted against BTP by any third parties with respect to patent infringement or any other type of liability relevant to licensing or sub-licensing of the Sublicensed Technology.

 

 

4.5

The execution of this Agreement by BTP shall not contravene any provision of law or any contract to which BTP is a party. The execution of this Agreement by BOP shall not contravene any provision of law or any contract to which BOP is a party.

 

5.

Other Considerations; General Provisions

 

 

5.1

Confidentiality: In fulfilling their obligations under this Sublicense Agreement, it may be desirable or necessary for BTP and BOP to disclose to one another certain confidential information. In the event of receipt of such confidential information, the receiving party agrees to preserve such information as confidential and not disclose it to third parties or to use it except where legally or commercially required to do so, in the reasonable opinion of counsel to the disclosing party.

 

 

5.2

Governing law: This Agreement shall be construed and enforced in accordance with the substantive laws of the State of New York, without regard to the principles thereof regarding the choice of law.

 

 

5.3

Severability: If any provision(s) of this Sublicense Agreement shall be determined to be invalid or unenforceable, the validity and effect of the other provisions of this Sublicense Agreement shall not be affected thereby.

 

 

5.4

Waiver: The waiver by either party or the failure by either party to claim a breach of any provision of this Sublicense Agreement shall not be deemed to constitute a waiver or estoppel with respect to any subsequent breach or with respect to any provision thereof.

 

 

5.5

Successors and Assigns: This Sublicense Agreement shall be binding upon and shall inure to the benefit of the Parties and their respective successors and assigns.

 

3


CONFIDENTIAL TREATMENT REQUESTED

 

 

5.6

Further Assurances: Each Party covenants and agrees to use commercially reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things reasonably required, necessary or appropriate, in good faith, to make effective the transactions contemplated by this Sublicense Agreement, including, without limitation, the conveyance of the Sublicensed Technology.

 

 

5.7

Counterparts: This Sublicense Agreement may be executed in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute a single instrument.

IN WITNESS WHEREOF, the parties have executed this Agreement by their duly authorized representatives as of February 16, 2005.

 

 

 

 

 

 

 

 

 

 

Bridge Therapeutic Products Inc.

 

 

 

Bridge Oncology Products Inc.

 

 

 

 

 

Signature:

 

/s/ Jeffrey B. Davis

 

 

 

Signature:

 

/s/ Steven H. Rouhandeh

 

 

 

 

 

Name:

 

Jeffrey B. Davis

 

 

 

Name:

 

Steven H. Rouhandeh

 

 

 

 

 

Position:

 

Chairman

 

 

 

Position:

 

Chairman

 

 

 

 

 

Date:

 

2/16/05

 

 

 

Date:

 

2/16/05

 

4


CONFIDENTIAL TREATMENT REQUESTED

 

EXHIBIT 1

PHS P ATENT L ICENSE

A GREEMENT B ETWEEN

THE U NITED S TATES P UBLIC H EALTH S ERVICE AND

N ATIONAL I NSTITUTE OF H EALTH ,

ON THE ONE HAND ,

AND

E LAN P HARMACEUTICAL R ESEARCH C ORPORATION ,

ON THE OTHER HAND

(A SSIGNED AND N OVATED TO V ECTRA M ED , I NC .

ON J UNE  27, 2003 AND

A SSIGNED AND N OVATED TO

V IRIUM P HARMACEUTICALS , I NC .

ON J ANUARY  5, 2005)

 

1


CONFIDENTIAL TREATMENT REQUESTED

 

PHS PATENT LICENSE AGREEMENT — EXCLUSIVE

PHS and LICENSEE agreement as follows:

 

1.

BACKGROUND

 

 

1.1

In the course of conducting biomedical and behavioral research funded by LICENSEE, Dr. Dvorit Samid, a PHS employee, previously an investigator with the Uniformed Services University of the Health Services (“USUHS”), made inventions that may have commercial applicability.

 

 

1.2

By assignment of rights from Dr. Samid and the Department of the Army (“DOA”), DHHS, on behalf of the United States Government, owns the intellectual property rights claimed in any United States and foreign patent applications or patents corresponding to the assigned inventions. DHHS also owns any tangible embodiments of these inventions actually reduced to practice by DOA or PHS.

 

 

1.3

The Assistant Secretary for Health of DHHS has delegated to PHS the authority to enter into this Agreement for licensing of rights to these inventions under 35 U.S.C. §§ 200-212, the Federal Technology Transfer Act of 1986, 15 U.S.C. § 3710a, and/or the regulations governing the licensing of Government-owned inventions, 37 C.F.R. Part 404.

 

 

1.4

PHS desires to transfer these inventions to the private sector through commercialization licenses to facilitate the commercial development of products and processes for public use and benefit.

 

 

1.5

LICENSEE desires to acquire commercialization rights to certain of these inventions in order to develop processes, methods or marketable products for public use and benefit.

 

2.

DEFINITIONS

 

 

2.1

“Licensed Patent Rights” shall mean:

2.1.1 U.S. patent applications and patents listed in Appendix A, all divisions and continuations of these applications, all patents issuing from such applications, divisions, and continuations, and any reissues, re-examinations, and extensions of all such patents;

2.1.2 to the extent that the following contain one or more claims directed to the invention or inventions claimed in a) above: 1) continuations-in-part of a) above; 2) all divisions and continuations of these continuations-in-part; 3) all patents issuing from such continuations-in-part, divisions, and continuations; and 4) any reissues, re-examinations, and extensions of all such patents;

 

2


CONFIDENTIAL TREATMENT REQUESTED

 

2.1.3 to the extent that the following contain one or more claims directed to the invention or inventions claimed in a) above: all counterpart foreign applications and patents to a) and b) above, including those listed in Appendix A.

Licensed Patent Rights shall not include b) or c) above to the extent that they contain one or more claims directed to new matter which is not the subject matter of a claim in a) above.

 

 

2.2

“Licensed Product(s)” means tangible materials which, in the course of manufacture, use or sale would, in the absence of this Agreement, infringe one or more claims of the Licensed Patent Rights that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

 

 

2.3

“Licensed Process(es)” means processes which, in the course of being practiced would, in the absence of this Agreement, infringe one or more claims of the Licensed Patent Rights that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

 

 

2.4

“Licensed Territory” means the geographical area identified in Appendix B.

 

 

2.5

“Net Sales” means the total gross receipts for sales of Licensed Products or practice of Licensed Processes by or on behalf of LICENSEE or its sublicensees, and from leasing, renting, or otherwise making Licensed Products available to others without sale or other dispositions, whether invoiced or not, less returns and allowances actually granted, packing costs, insurance costs, freight out, taxes or excise duties imposed on the transaction (if separately invoiced), and wholesaler and cash discounts in amounts customary in the trade. No deductions shall be made for commissions paid to individuals, whether they be with independent sales agencies or regularly employed by LICENSEE, or sublicensees, and on its payroll, or for the cost of collections.

 

 

2.6

“First Commercial Sale” means the initial transfer by or on behalf of LICENSEE or its sublicensees, of Licensed Products or the initial practice of a Licensed Process by or on behalf of LICENSEE or its sublicensees in exchange for cash or some equivalent to which value can be assigned for the purpose of determining Net Sales.

 

 

2.7

“Government” means the government of the United States of America.

 

 

2.8

“Licensed Fields of Use” means the fields of use identified in Appendix B.

 

3.

GRANT OF RIGHTS

 

 

3.1

PHS hereby grants and LICENSEE accepts, subject to the terms and conditions of this Agreement, an exclusive license to LICENSEE under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used and

 

3


CONFIDENTIAL TREATMENT REQUESTED

 

 

to sell and have sold any Licensed Products in the Licensed Fields of Use and to practice and have practicedany Licensed Processes in the Licensed Fields of Use.

 

 

3.2

This Agreement confers no license or rights by implication, estoppel or otherwise under any patent applications or patents of PHS other than Licensed Patent Rights regardless of whether such patents are dominant or subordinate to Licensed Patent Rights.

 

4.

SUBLICENSING

 

 

4.1

Upon written approval by PHS, which approval will not be unreasonably withheld, LICENSEE may enter into sublicensing agreements under the Licensed Patent Rights.

 

 

4.2

LICENSEE agrees that any sublicenses granted by it shall provide that the obligations to PHS of Paragraphs 5.01-5.05, 8.01, 10.01, 10.02, 12.05 and 13.08-13.11 of this Agreement shall be binding upon the sublicensee as if it were a party to this Agreement. LICENSEE further agrees to attach copies of these Paragraphs to all sublicense agreements.

 

 

4.3

Any sublicenses granted by LICENSEE shall provide for the termination of the sublicense, or the conversion to a license directly between such sublicensees and PHS, at the option of the sublicensee, upon termination of this Agreement under Article 13. Such conversion is subject to PHS approval and contingent upon acceptance by the sublicensee of the remaining provisions of this Agreement.

 

 

4.4

LICENSEE agrees to forward to PHS a copy of each fully executed sublicense agreement postmarked within sixty (60) days of the execution of such agreement.

 

5.

STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS

 

 

5.1

PHS reserves on behalf of the Government an irrevocable, nonexclusive, nontransferable, royalty-free license for the practice of all inventions licensed under the Licensed Patent Rights throughout the world by or on behalf of the Government and on behalf of any foreign government or international organization pursuant to any existing or future treaty or agreement to which the Government is a signatory.

 

 

5.2

LICENSEE agrees that products used or sold in the United States embodying Licensed Products or produced through use of Licensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from PHS.

 

 

5.3

LICENSEE acknowledges that PHS may enter into a future Cooperative Research and Development Agreements (“CRADAs”) under the Federal Technology Transfer Act of 1986 that relate to the subject matter of this Agreement. LICENSEE agrees not to unreasonably deny requests for sublicense or cross

 

4


CONFIDENTIAL TREATMENT REQUESTED

 

 

license rights from such future collaborators with PHS when acquiring such derivative rights is necessary in order to make a CRADA project feasible. PHS will endeavor to give LICENSEE a reasonable opportunity to join as a party to the proposed CRADA prior to its initiation and to obtain reciprocal patent rights in any resultant inventions.

 

 

5.4

In addition to the reserved license of Paragraph 5.01 above, PHS reserves the right to grant nonexclusive licenses to make and to use the inventions defined by the Licensed Patent Rights for purposes of research involving the inventions themselves, and not for purposes of commercial manufacture or in lieu of purchase if the inventions are available as commercial products for research purposes. The purpose of this research license is to encourage basic research, whether conducted at an academic or corporate facility. In order to safeguard the Licensed Patent Rights, however, PHS shall obtain the consent of LICENSEE before granting to commercial entities a research license or providing to them research samples of the materials claimed in the Licensed Patent Rights, which consent shall not be unreasonably withheld.

 

6.

ROYALTIES AND REIMBURSEMENT

 

 

6.1

LICENSEE agrees to pay to PHS a noncreditable, nonrefundable license issue royalty as set forth in Appendix C within thirty (30) days from the date that this Agreement becomes effective.

 

 

6.2

LICENSEE agrees to pay to PHS a nonrefundable minimum annual royalty as set forth in Appendix C. The minimum annual royalty is due and payable on January 1 of each calendar year and may be credited against any earned royalties due for sales made in that year. The minimum annual royalty due the first calendar year of this Agreement may be prorated according to the fraction of the calendar year remaining between the effective date of this Agreement and the next subsequent January 1.

 

 

6.3

LICENSEE agrees to pay PHS Earned Royalties as set forth in Appendix C.

 

 

6.4

LICENSEE agrees to pay PHS Benchmark Royalties as set forth in Appendix C.

 

 

6.5

A claim of a patent or patent application licensed under this Agreement shall cease to fall within the Licensed Patent Rights for the purpose of computing the minimum annual royalty and earned royalty payments in any given country on the earliest of the dates that (a) the claim has been abandoned but not continued, (b) the patent expires, (c) the patent is no longer maintained by the Government, or (d) all claims of the Licensed Patent Rights have been held to be invalid or unenforceable by an unappealed or unappealable decision of a court of competent jurisdiction or administrative agency.

 

 

6.6

No multiple royalties shall be payable because any Licensed Products or Licensed Processes are covered by more than one of the Licensed Patent Rights.

 

5


CONFIDENTIAL TREATMENT REQUESTED

 

 

6.7

On sales of Licensed Products by LICENSEE to sublicensees or affiliated parties or on sales made in other than an arm’s length transaction, the value of the Net Sales attributed under this Article 6 to such a transaction shall be that which would have been received in an arm’s length transaction, based on sales of like quantity and quality products on or about the time of such transaction.

 

 

6.8

As an additional royalty, LICENSEE agrees to pay PHS, within sixty (60) days of PHS’s submission of a statement and request for payment, an amount equivalent to all reasonable expenses previously incurred by PHS in the preparation,


 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more