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EXCLUSIVE LICENSE AGREEMENT

License Agreement

EXCLUSIVE LICENSE AGREEMENT | Document Parties: D-NOVO THERAPEUTICS, INC. | OREGON HEALTH AND SCIENCE UNIVERSITY You are currently viewing:
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D-NOVO THERAPEUTICS, INC. | OREGON HEALTH AND SCIENCE UNIVERSITY

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Title: EXCLUSIVE LICENSE AGREEMENT
Governing Law: Oregon     Date: 3/28/2006
Industry: Biotechnology and Drugs    

EXCLUSIVE LICENSE AGREEMENT, Parties: d-novo therapeutics  inc. , oregon health and science university
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Exhibit 10.4

 

EXCLUSIVE LICENSE AGREEMENT

BETWEEN OHSU AND

D-NOVO THERAPEUTICS, INC.

 

This Agreement is made and entered into between the Oregon Health & Science University (hereinafter OHSU ) having offices at 3181 S. W. Sam Jackson Park Road, Portland, Oregon 97201-3098, and D-Novo Therapeutics, Inc. (hereinafter Licensee ), a California corporation having offices at 28202 Cabot Road, Suite 200, Laguna Niguel, California 92677 on this 27th day of June, 2001 (“ Effective Date ”).

 

1.

BACKGROUND

 

1.01

In the course of fundamental research programs at OHSU , inventions were conceived which relate to Vitamin D and its analogs in oncology and other disease therapies. The intellectual property rights resulting from these inventions (and licensed through this Agreement ) are subject to the conditions set forth in 37 CFR Part 401.

 

1.02

By assignment of the inventions as described in OHSU Disclosure Number 97/413 from the inventors, OHSU is the owner of certain patent rights and desires to grant licenses under those rights to Licensee for development of products and processes for public use and benefit. These patent rights include, but are not limited to, those rights in PCT Patent Application #WO 99/49870 “Vitamin D and its Analogs in the Treatment of Tumors and Other Hyperproliferative Disorders” and other patent applications related to the pulsatile high-dose administration of Vitamin D and analogs in tumors and other hyperproliferative disorders.

 

1.03

Licensee desires to develop processes and methods and marketable products for public use and benefit by using Licensed Patent Rights .

 

2.

DEFINITIONS

 

2.01

Affiliate ” means any legal entity directly or indirectly controlling, controlled by or under common control with Licensee . Any Affiliate or any joint venture or other entity formed by Licensee that distributes Licensed Products or Licensed Processes shall execute (a) this Agreement or (b) a written joinder agreement in a form satisfactory to OHSU , and will be a Licensee for the purposes of this Agreement (other than for the purposes of Section 6.01). Licensee shall be responsible for such Affiliate ’s or entity’s performance of its obligations under this Agreement .

 

2.02

Development Plan ” means a plans) for the development and/6r marketing of the Licensed Patent Rights that demonstrates Licensee ’s capability to bring the Licensed Patent Rights to practical application.

 

2.03

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 a 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 .

 

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2.04

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

 

2.05

Licensed Fields of Use ” means for all uses related to oncology and other disease therapies.

 

2.06

Licensed Patent Rights ” shall mean:

 

 

a)

U.S. and foreign patent applications and patents listed in Appendix A or subsequently added to Appendix A by agreement of the parties, all divisions and continuations of these applications, all patents issuing from such applications, divisions, and continuations, and any reissues, reexaminations, and extensions of all such patents;

 

 

b)

and to the extent that the following contain one or more claims directed to the invention or inventions claimed in a) above: i) continuations-in-part of a) above; ii) all divisions and continuations of these continuations-in-part; iii) all patents issuing from such continuations-in-part, divisions, and continuations; and iv) any reissues, reexaminations, and extensions of all such patents.

 

Licensed Patent Rights shall not include claims in b) above to the extent that they are directed to new matter which is not the disclosed in the specifications of a) above.

 

2.07

Licensed Product(s) ” means tangible materials which, in the course of manufacture, use,, or sale would be covered by 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.

 

2.08

Licensed Process(es) ” means processes which, in the course of being practiced would be covered by 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.

 

2.09

Licensed Territory ” means the world.

 

2.10

Net Sales ” means the total gross receipts for sales of Licensed Products or practice of Licensed Processes by or on behalf of Licensee , and from leasing, renting, or otherwise making Licensed Products or Licensed Processes 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.

 

2.11

Trigger Event ” means any of the following:

 

 

a)

if Licensee becomes insolvent, bankrupt or generally fails to pay its debts as such debts become due; is adjudicated insolvent or bankrupt; admits in writing its

 

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inability to pay its debts; or shall suffer a custodian, receiver or trustee for it or substantially all of its property to be appointed and, if appointed without its consent, not be discharged within thirty (30) days; makes an assignment for the benefit of creditors; or suffers proceedings under any law related to bankruptcy, insolvency, liquidation or the reorganization, readjustment or the release of debtors to be instituted against it and, if contested by it, not dismissed or stayed within ten (10) days;

 

 

b)

if proceedings under any law related to bankruptcy, insolvency, liquidation, or the reorganization, readjustment or the release of debtors are instituted or commenced by Licensee ;

 

 

c)

if any order for relief is entered relating to any of the proceedings described in Paragraphs 2.11(a) or (b);

 

 

d)

if Licensee shall call a meeting of its creditors with a view to arranging a composition or adjustment of its debts;

 

 

e)

if Licensee shall by any act or failure to act indicate its consent to, approval of or acquiescence in any of the proceedings described in Paragraphs 2.11 (a), (b), (c) or (d); or

 

 

f)

if Licensee fails to make commercially reasonable efforts to cure any breach by a sublicensee of its agreement with Licensee related to the Licensed Patent Rights , or if after Licensee makes such commercially reasonable efforts and sublicensee is still in breach, Licensee fails to terminate such sublicensee agreement within a reasonable period of time, but in no event longer than one hundred and twenty (120) days.

 

3.

GRANT OF RIGHTS

 

3.01

OHSU 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, have made, use, offer for sale, sell and import any Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the Licensed Fields of Use .

 

3.02

At no cost to Licensee , for two (2) years from the Effective Date: 1) for all inventions conceived within that two (2) years that are improvements to the patents and patent applications listed in Appendix A, Licensee shall have the right to add said patents and patent applications to Appendix A; and, 2) Licensee shall have the right to add patents and patent applications acquired or licensed by or to OHSU that relate to the pulsatile high-dose administration of Vitamin D and analogs in tumors and other hyperproliferative disorders. In that event, the terms and conditions governing said additional patent applications and patents added to Appendix A shall be the terms and conditions provided for herein, as modified by any further written agreement of the parties. After two (2) years from the Effective Date, the parties agree that Licensee will have the first right to negotiate in good faith regarding any additional patent rights that

 

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relate to pulsatile high-dose administration of Vitamin D and analogs in tumors and other hyperproliferative disorders that Licensee desires to acquire from OHSU .

 

3.03

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

 

3.04

The license of Paragraph 3.01 above is exclusive, except that OHSU may use, and permit other academic and nonprofit organizations to use, the Licensed Patent Rights for educational and research purposes, and further, the U.S. government may use the Licensed Patent Rights as provided for in Paragraph 5.01.

 

3.05

Licensee hereby agrees that it shall not manufacture, distribute; market or sell products that directly compete with Licensed Products or practice processes that directly compete with Licensed Processes .

 

4.

SUBLICENSING

 

4.01

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

 

4.02

Licensee agrees that any sublicenses granted by it shall provide that the obligations to OHSU of Paragraphs 5.01, 5.02, 8.01, 10.01, 10.02, 12.01-12.05, and 13.01-13.10 of this Agreement shall be binding upon any sublicensee as if it were a party to this Agreement . Licensee further agrees to attach copies of these Paragraphs to all sublicense agreements.

 

4.03

Licensee agrees to prohibit any sublicensee from further sublicensing.

 

4.04

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

 

4.05

Licensee agrees to forward to OHSU a copy of each fully executed sublicense agreement postmarked within thirty (30) days of the execution of such agreement.

 

4.06

In the event of a default under Article 13 hereunder, all payments then or thereafter due to Licensee from each of its sublicensees shall, upon notice from OHSU to any such sublicensee, become owed directly to OHSU for the account of Licensee ; provided that OHSU shall remit to Licensee the amount by which such payments in the aggregate exceed the total amount owed by Licensee to OHSU .

 

4.07

Even if Licensee enters into sublicenses, Licensee remains primarily liable to OHSU for all of Licensee ’s duties and obligations contained in this Agreement .

 

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5.

STATUTORY AND OHSU REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS

 

5.01

OHSU 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.

 

5.02

Licensee agrees that products used or sold in the United States embodying Licensed Patent Rights shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from the Government .

 

6.

ROYALTIES AND REIMBURSEMENT

 

6.01

 

 

 

a)

Promptly following the execution of this Agreement , Licensee shall issue to OHSU as a license issuance royalty 800,000 shares of the Common Stock of Licensee , which shares will represent approximately [*]% of the shares of the Common Stock of Licensee deemed to be outstanding on a fully-diluted basis after giving effect to such issuance. A copy of a Term Sheet relating to Licensee ’s proposed Series A-1 Preferred Stock and Series A-2 Preferred Stock financing transactions wherein Licensee will raise an aggregate of $[*] is attached hereto as Appendix B. It is anticipated that after the closing of the Series A-1 Preferred Stock financing, wherein it is anticipated that Licensee will raise $[*], the shares issued to OHSU will represent approximately [*]% of the Common Stock of Licensee deemed to be outstanding on a fully diluted basis and after the closing of the Series A-2 Preferred Stock financing transaction, wherein it is anticipated that Licensee will raise an aggregate of $[*], the shares issued to OHSU will represent approximately [*]% of the Common Stock of Licensee deemed to be outstanding on a fully-diluted basis The shares of Common Stock to be issued to Licensee shall not be subject to forfeiture and shall not be used as an offset or credit against future royalties. This Agreement is conditioned upon Licensee raising cash equity on substantially the terms described in the Series A-1/Series A-2 Term Sheet attached as Appendix B.

 

 

b)

Concurrently with the issuance of the shares of Common Stock to OHSU , OHSU shall execute an investment representation letter substantially in the form attached hereto as Appendix C, and OHSU and Licensee shall execute a Stock Restriction Agreement substantially in the form attached hereto as Appendix D (the “Stock Restriction Agreement ”). Licensee warrants and represents that (i) the Stock Restriction Agreement is no more restrictive to the stockholder than any other

 

[*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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restriction agreement now in use or contemplated to be entered into between Licensee and holders of its Common Stock and (ii) all holders of Common Stock of Licensee who are employees and/or officers of Licensee have entered into or will enter into a restriction agreement which includes restrictions substantially the same as those set forth in the Stock Restriction Agreement .

 

 

c)

Licensee shall grant to OHSU the same “piggyback” registration rights as are granted to investors (the “Investors”) participating in Licensee ’s Series A-1 Preferred Stock and Series A-2 Preferred Stock financing transactions. Licensee will furnish to OHSU quarterly and annual financial statements and such other financial information and reports as are furnished to the Investors, with such statements, information and reports being furnished to OHSU at the same time they are furnished to the Investors.

 

6.02

Licensee agrees to pay OHSU earned royalties as follows:

 

 

a)

[*] percent ([*]%) royalty on Net Sales by Licensee .

 

 

b)

In the event that any Licensed Product or practice of Licensed Process incorporates other patent rights or rights in other intellectual property for which royalties are due by Licensee , then Licensee shall not be required to stack its royalty payments, and the parties shall negotiate in goad faith among Licensee , OHSU and the other holders of the intellectual property rights to determine the division of the royalties so that Licensee shall not be required to pay an aggregate royalty of more than [*] percent ([*]%) of Net Sales . However, in no event shall the share of OHSU ’s royalty be less than [*] percent ([*]%) of Net Sales of the Licensed Products or Licensed Processes .

 

6.03

Licensee agrees to pay OHSU milestone royalties and market launch royalties as follows:

 

 

a)

$[*] upon successful completion of [*] for any product covered by Licensed Patent Rights .

 

 

b)

$[*] upon successful completion of [*] for any product, covered by Licensed Patent Rights .

 

 

c)

$[*] upon successful completion of [*] for any product covered by Licensed Patent Rights .

 

[*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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d)

In the event that any product covered by Licensed Patent Rights fails after completion of Phase III clinical trials, and a substitute product (backup compound) covered by the Licensed Patent Rights must be substituted for the same indication, no additional Phase I or II milestone royalties shall be due for any backup compound(s).

 

 

e)

$[*] upon [*] for any product covered by Licensed Patent Rights .

 

 

f)

Milestone royalties set forth in Paragraphs 6.03(a)-(c) are nonrefundable, and shall have no credit or offset against future royalties. Market launch royalties set forth in Paragraph 6.03(e) are refundable and are to be fully credited against future royalties due.

 

6.04

Licensee shall pay to OHSU a sublicensing royalty of [*] percent ([*]%) of any monies or other consideration received by Licensee from any sublicensing of the Licensed Patent Rights , including without limitation any sublicense initiation fees, milestone payments, royalties on sales, and any premium on any equity investment by sublicensees. Any non-cash consideration received by the Licensee from such sublicensees shall be valued at its fair market value as of the date of receipt. However, said payments from any sublicensee shall not include consideration received for cost reimbursement of R&D services, and no amount shall be due to OHSU from Licensee for consideration received as reimbursement for such R&D services.

 

6.05

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 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 OHSU , 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.

 

6.06

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

 

6.07

On sales of Licensed Products and Licensed Processes by Licensee made in other than an arm’s-length transaction. The value of the N


 
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