Exhibit 10.2
AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT
BETWEEN OHSU AND
NOVACEA, INC.
ThisAmended and Restated Agreement (hereinafter this “Agreement”) is made and entered into as of May 25, 2007 (“Effective Date”) between the Oregon Health & Science University (hereinafterOHSU) having offices at 2525 S.W. First Avenue, Suite 120, Portland, Oregon 97201, and Novacea, Inc. (formerly known as D-Novo Therapeutics, Inc.) (hereinafterLicensee), a Delaware corporation having offices at 601 Gateway Blvd., Suite 800, South San Francisco, California 94080; and hereby amends and restates the Exclusive License Agreement between OHSU and Licensee effective June 27, 2001 (the “Original License Agreement”).
| 1.01 | In the course of fundamental research programs atOHSU, 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 thisAgreement) are subject to the conditions set forth in 37 CFR Part 401. |
| 1.02 | By assignment of the inventions as described inOHSU Disclosure Number 97/413 from the inventors,OHSU is the owner of certain patent rights and desires to grant licenses under those rights toLicensee 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, including, but not limited to those listed in Appendix A to thisAgreement. |
| 1.03 | Licensee desires to develop processes and methods and marketable products for public use and benefit by using Licensed Patent Rights. |
| 1.04 | OHSU and Licensee entered into an agreement dated June 27th, 2001, the Original License Agreement, which was subsequently amended on November 21, 2005. |
| 1.05 | OHSU and Licensee hereby seek to further amend and restate the Original License Agreement as indicated herein. |
| 2.01 | “Affiliate” means any legal entity directly or indirectly controlling, controlled by or under common control withLicensee. AnyAffiliate or any joint venture or other entity formed byLicensee that distributesLicensed Products orLicensed Processes shall execute (a) thisAgreement or (b) a written joinder agreement in a form satisfactory toOHSU, and will be aLicensee for the purposes of thisAgreement (other than for the purposes of Section 6.01).Licensee shall be responsible for suchAffiliate’s or entity’s performance of its obligations under thisAgreement. |
| 2.02 | “Development Plan” means a plan(s) for the development and/or marketing of theLicensed Patent Rights that demonstratesLicensee’s capability to bring theLicensed Patent Rights to practical application as such term is defined in 35 U.S.C. §201(f). |
| 2.03 | “First Commercial Sale” means the initial transfer by or on behalf ofLicensee or its sublicensees ofLicensed Products or the initial practice of aLicensed Process by or on behalf ofLicensee or its sublicensees in exchange for cash or some equivalent to which value can be assigned for the purpose of determiningNet Sales. For the avoidance of doubt, (1) sales for test marketing, sampling and promotional uses, clinical trial purposes or compassionate or similar use and (2) transfers ofLicensed Products, whether by sale or otherwise, or practice of theLicensed Process, as betweenAffiliates ofLicensee, orAffiliates of its sublicensees, will not constitute aFirst Commercial Sale or a sale for the purpose of determiningNet Sales, provided that (i) theAffiliate to whom the transfer is made is not an end-user for the purpose of patient administration, and (ii) ifLicensee, or a sublicense, sells aLicensed Product orLicensed Process to anAffiliate for resale,Net Sales will include any amounts received by suchAffiliate from third parties on the resale of suchLicensed Product orLicensed Process. |
| 2.04 | “Government” means the government of the United States of America. |
| 2.05 | “Licensed Fields of Use” means all prophylactic, therapeutic, and diagnostic uses in humans and/or animals. |
| 2.06 | “Licensed Know-How” means all proprietary information, methods, processes, techniques, data and biologic materials (including, without limitation, pre-clinical and clinical data) which are in the possession of or controlled byOHSU during the term of thisAgreement, whichOHSUis free to license or sublicense, and which is necessary or useful for the manufacture, use or sale of aLicensed Productin theLicensed Fields of Use or to practice anyLicensed Process in theLicensed Fields of Use in theLicensed Territory. Except as otherwise expressly agreed by the parties, the license toLicensee ofLicensed Know-How set forth above shall not obligateOHSUto conduct additional research or otherwise initiate any action with respect to creation of newLicensed Know-How. |
| 2.07 | “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. |
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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.
| 2.08 | “Licensed Product(s)” means tangible materials which, in the course of manufacture, use, or sale would be covered by one or more claims of theLicensed 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 Process(es)” means processes which, in the course of being practiced would be covered by one or more claims of theLicensed Patent Rights that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction. |
| 2.10 | “Licensed Territory” means the world. |
| 2.11 | “Net Sales” means the aggregate gross amount invoiced byLicensee or itsAffiliateson all sales or transfers for consideration ofLicensedProduct orLicensed Process in theLicensed Territory to a third party, less the following deductions to the extent such deductions are documented and (i) listed in the invoice as a credit or charge added to the unit price of aLicensed Product orLicensed Process or (ii) directly paid or actually incurred and not reimbursed to or recovered byLicensee or itsAffiliateswith respect to the sale of suchLicensed Product orLicensed Process: |
| | a) | bad debts actually written off which are attributable to sales ofLicensed Product orLicensed Process; |
| | b) | trade, quantity and cash discounts and any other adjustments, including, without limitation, those granted on account of price adjustments, billing errors, rejected goods, damaged goods, returns, recalls, rebates, chargeback rebates, fees, reimbursements or similar payments granted or given to wholesalers or other distributors, buying groups, health care insurance carriers or other institutions: |
| | c) | freight, packing, handling, shipping, postage and insurance charges to the extent that they are included in the price or otherwise paid by the purchaser; |
| | d) | customs or excise taxes, including, without limitation, import duties, sales tax and other taxes (except income taxes) or duties relating to sales, |
| | e) | distribution, packing, handling and transportation charges forLicensed Productto the extent that they are included in the price or otherwise paid by the customer; |
The foregoing adjustments shall be consistent with customary accounting practices within the selling party and itsAffiliates (or their respective sublicensees) and in accordance with United States Generally Accepted Accounting Principles (“GAAP”), consistently applied.
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It is understood, however, that in certain countries,Licensee or itsAffiliatesmay commercializeLicensed Products through a third party distributor or agent under an arrangement in whichLicensee or itsAffiliates, (x) transfer theLicensed Product to such distributor or agent at a fixed price that is not necessarily related to the final selling price of the distributor or agent, and (y) are not responsible for marketing and promoting suchLicensed Product in such countries and receive no compensation from the sale of suchLicensed Products by the distributor or agent. To the extent that such third party distributors or agents would be considered “sublicensees”, theOHSU andLicensee agree that the gross invoiced sales prices for the sale of theLicensed Product byLicensee or itsAffiliatesto such third parties shall be the price to be used for purposes of computingNet Sales in such countries provided, however, that (i) such gross invoiced sales prices are determined prior to any deductions by the selling party, (ii) the selling party receives no form of consideration other than such gross invoiced sales prices from such third party distributors or agents.
| 2.12 | “Reasonable Commercial Efforts”means efforts and resources commonly used in the pharmaceutical industry for a drug of similar commercial potential at a similar stage in its lifecycle, taking into consideration its safety and efficacy, the cost to develop and commercialize the product, its competitiveness compared to alternative products, the proprietary position of the product, the scope, timing and likelihood of regulatory approvals, the profitability of the product and other relevant factors. |
| 2.13 | “Trigger Event” means any of the following: |
| | a) | ifLicensee becomes insolvent, bankrupt or generally fails to pay its debts as such debts become due; is adjudicated insolvent or bankrupt; admits in writing its 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 byLicensee; |
| | c) | if any order for relief is entered relating to any of the proceedings described in Paragraphs 2.13(a) or (b); |
| | d) | ifLicensee shall call a meeting of its creditors with a view to arranging a composition or adjustment of its debts; |
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| | e) | ifLicensee shall by any act or failure to act indicate its consent to, approval of or acquiescence in any of the proceedings described in Paragraphs 2.13 (a), (b), (c) or (d); or |
| | f) | ifLicensee fails to make commercially reasonable efforts to cure any material breach by a sublicensee of any provision of its agreement with Licensee that is directly related to theLicensed Patent Rights and would have a material adverse impact onOHSU’s rights under thisAgreement, or if afterLicensee makes such commercially reasonable efforts and sublicensee is still in material breach for which there is no other adequate remedy other than termination,Licensee fails to terminate such sublicense agreement within a reasonable period of time, but in no event longer than one hundred eighty (180) days. |
| 3.01 | OHSU hereby grants andLicensee accepts, subject to the terms and conditions of thisAgreement, an exclusive license toLicensee under theLicensed Patent Rights andLicensed Know-Howin theLicensed Territory to make, have made, use, offer for sale, sell, export, and import anyLicensed Products in theLicensed Fields of Use and to practice and have practiced anyLicensed Processes in theLicensed Fields of Use. |
| 3.02 | At no cost toLicensee, for two (2) years from the effective date of theOriginal License Agreement: 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 toOHSU 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 of theOriginal License Agreement, the parties agree thatLicensee will have the first right to negotiate in good faith regarding any additional patent rights that relate to pulsatile high-dose administration of Vitamin D and analogs in tumors and other hyperproliferative disorders thatLicensee desires to acquire fromOHSU. |
| 3.03 | ThisAgreement confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents ofOHSU other thanLicensed Patent Rights regardless of whether such patents are dominant or subordinate toLicensed Patent Rights. |
| 3.04 | The license of Paragraph 3.01 above is exclusive, except that (i) OHSU may practice and use theLicensed Patent Rights andLicensed Know-Howfor educational and non-commercial research purposes, (ii) OHSU may grant non-exclusive licenses to other universities, academic institutions, and nonprofit research organizations, with whom it has a contractual non-commercial research collaboration, to practice theLicensed Patent RightsandLicensed Know-How for educational and non-commercial research purposes, and (iii) the U.S. government may use theLicensed Patent Rights as provided for in Paragraph 5.01. |
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| 4.01 | Upon written approval byOHSU, which approval will not be unreasonably withheld,Licensee may enter into sublicensing agreements under theLicensed Patent Rights. |
| 4.02 | Licensee agrees that any sublicenses granted by it shall provide that the obligations toOHSU of Paragraphs 5.01, 5.02, 8.01, 10.01, 10.02, 12.01-12.05, and 13.01-13.10 of thisAgreement shall be binding upon any sublicensee as if it were a party to thisAgreement.Licensee further agrees to attach copies of these Paragraphs to all sublicense agreements. |
| 4.03 | Licensee shall have the right to enter into sub-licensing arrangements for the rights, privileges and licenses granted hereunder. Any sublicensee shall have the right to grant further sublicenses as necessary to meet its obligations under any sublicense agreement withLicensee, provided that there be no dilution of the royalties due toOHSUunder Paragraph 6.02, 6.03, and 6.04. Any further sublicensee will have no right to grant further sublicenses. |
| 4.04 | Any sublicenses granted byLicensee shall provide for the termination of the sublicense, or the conversion to a license directly between such sublicensees andOHSU, at the option of the sublicensee, upon termination of thisAgreement under Article 13, provided that, at the time of the election of such conversion, such sublicensee is not in material breach of its sublicense agreement withLicensee. Such conversion is contingent upon acceptance by the sublicensee of the provisions of thisAgreement. |
| 4.05 | Licensee agrees to forward toOHSU a copy of each fully executed sublicense agreement postmarked within thirty (30) days of the execution of such agreement, provided thatLicensee may, in its sole discretion, redact from such copy technical information that does not relate toLicensed Patent Rights, and economic or competitive terms that do not relate to consideration paid for, or other financial obligations relating to, the grant of the sublicense under theLicensed Patent Rights. |
| 4.06 | In the event of a default under Article 13 hereunder, all portions relating to thisAgreementof any payments then or thereafter due toLicensee from each of its sublicensees shall, to the extent not yet paid toLicensee as of the effective date of any termination byOHSU due to such uncured default, upon notice fromOHSU to any such sublicensee, become owed directly toOHSU for the account ofLicensee; provided thatOHSU shall remit toLicensee the amount by which such payments in the aggregate exceed the total owed by Licensee toOHSU. |
| 4.07 | Even ifLicensee enters into sublicenses,Licensee remains primarily liable toOHSU for all ofLicensee’s duties and obligations contained in thisAgreement. |
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| 5. | STATUTORY AND OHSU REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS |
| 5.01 | If and only to the extent required and applicable under 35. U.S.C. §202(c)(4),OHSU reserves on behalf of theGovernment an irrevocable, nonexclusive, nontransferable, royalty-free license for the practice of all subject inventions, as such term is defined in 35 U.S.C §201(e), licensed under theLicensed Patent Rights. |
| 5.02 | If and only to the extent required and applicable under 35 U.S.C §204,Licensee agrees that products used or sold in the United States embodyingLicensed Patent Rights that are subject inventions as defined in 35 U.S.C. §201(e) shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from theGovernment. |
| 6. | ROYALTIES AND REIMBURSEMENT |
| | a) | Promptly following the execution of theOriginal License Agreement,Licensee shall issue toOHSU as a license issuance royalty 800,000 shares of the Common Stock ofLicensee, which shares will represent approximately [*]% of the shares of the Common Stock ofLicensee deemed to be outstanding on a fully-diluted basis after giving effect to such issuance. A copy of a Term Sheet relating toLicensee’s proposed Series A-1 Preferred Stock and Series A-2 Preferred Stock financing transactions whereinLicensee 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 thatLicensee will raise $[*], the shares issued toOHSU will represent approximately [*]% of the Common Stock ofLicensee 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 thatLicensee will raise an aggregate of $[*], the shares issued toOHSU will represent approximately [*]% of the Common Stock ofLicensee deemed to be outstanding on a fully-diluted basis. The shares of Common Stock to be issued toLicensee shall not be subject to forfeiture and shall not be used as an offset or credit against future royalties. ThisAgreement is conditioned uponLicensee 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 toOHSU,OHSU shall execute an investment representation letter substantially in the form attached hereto as Appendix C, andOHSU andLicensee shall execute a Stock RestrictionAgreement substantially in the form attached hereto as Appendix D (the “Stock Restriction Agreement”).Licensee warrants and represents that (i) theStock Restriction Agreement is no more restrictive to the stockholder than any other restriction agreement now in use or contemplated to be entered into between |
| [*] | 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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| | Licensee and holders of its Common Stock and (ii) all holders of Common Stock ofLicensee who are employees and/or officers ofLicensee have entered into or will enter into a restriction agreement which includes restrictions substantially the same as those set forth in theStock Restriction Agreement. |
| | c) | Licensee shall grant toOHSU the same “piggyback” registration rights as are granted to investors (the “Investors”) participating inLicensee’s Series A-1 Preferred Stock and Series A-2 Preferred Stock financing transactions.Licensee will furnish toOHSU 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 toOHSU at the same time they are furnished to the Investors. |
| 6.02 | Licensee agrees to payOHSU earned royalties as follows: |
| | a) | [*] percent ([*]%) royalty onNet Sales byLicensee. |
| | b) | In the event that anyLicensed Product or practice ofLicensed Process incorporates other patent rights or rights in other intellectual property for which royalties are due byLicensee, thenLicensee shall not be required to stack its royalty payments, and the parties shall negotiate in good faith amongLicensee,OHSU and the other holders of the intellectual property rights to determine the division of the royalties so thatLicensee shall not be required to pay an aggregate royalty of more than [*] percent ([*]%) ofNet Sales. However, in no event shall the share ofOHSU’s royalty be less than [*] percent ([*]%) ofNet Sales of theLicensed Products orLicensed Processes. |
| 6.03 | Licensee agrees to payOHSU milestone royalties and market launch royalties as follows: |
| | a) | $[*] upon successful completion of [*] for any product covered byLicensed Patent Rights. |
| | b) | $[*] upon successful completion of [*] for any product, covered byLicensed Patent Rights. |
| | c) | $[*] upon successful completion of [*] for any product covered byLicensed Patent Rights. |
| | d) | In the event that any product covered byLicensed Patent Rights fails after completion of Phase III clinical trials, and a substitute product (backup compound) covered by theLicensed 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). |
| [*] | 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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| | e) | $[*] upon [*] for any product covered byLicensed 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 toOHSU a sublicensing royalty of fifteen percent (15%) of any monies or other consideration received byLicensee from any sublicensing of theLicensed 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 theLicensee 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 toOHSU fromLicensee for consideration received as reimbursement for such R&D services. |
| 6.05 | A claim of a patent or patent application licensed under thisAgreement shall cease to fall within theLicensed 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 byOHSU, or d) all claims of theLicensed 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 toOHSU because anyLicensed Products orLicensed Processes are covered by more than one of theLicensed Patent Rights. |
| 6.07 | On sales ofLicensed Products andLicensed Processes byLicensee made in other than an arm’s-length transaction. The value of theNet 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. |
| 6.08 | As an additional royalty,Licensee agrees to payOHSU, within sixty (60) days ofOHSU’s submission of a statement and request for payment, an amount equivalent to all reasonable expenses previously incurred byOHSU in the preparation, filing, prosecution, and maintenance ofLicensed Patent Rights.Licensee further agrees to payOHSU quarterly, within sixty (60) days ofOHSU’s submission of a statement and request for payment, a royalty amount equivalent to all such patent expenses incurred during, the previous calendar quarter, as of the date the statement and request for payment is sent byOHSU toLicensee.Licensee may elect to surrender its rights in any country of theLicensed Territory under anyLicensed Patent Rights upon sixty (60) days’ written notice toOHSU and owe no payment obligation under this Paragraph 6.08 for subsequent patent-related expenses incurred in that country. |
| [*] | 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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| 6.09 | Royalties due under this Article 6 shall be paid in U.S. dollars. For conversion of foreign currency to U.S. dollars, the conversion rate shall be the rate quoted in The Wall Street Journal on the last business day of the applicable calendar quarter or half-year, as applicable, that the payment is due. All checks and bank drafts shall be drawn on United States banks and shall be payable to Oregon Health & Science University at the address shown on the Signature Page below. Any loss of exchange, value, taxes, or other expenses incurred in the transfer or conversion to U.S. dollars shall be paid entirely byLicensee. |
| 6.10 | Amounts that are not paid when due shall accrue interest from the due date until paid, at a rate equal to one percent (1.0%) per month or part thereof (or the maximum allowed by law, if less). |
| 7. | DOMESTIC AND FOREIGN PATENT FILING, PROSECUTION, AND MAINTENANCE |
| 7.01 | OHSU in consultation withLicensee, and withLicensee’s approval, shall be responsible for the preparation, filing, prosecution, and maintenance of any and all patent applications or patents included in theLicensed Patent Rights.OHSU shall use patent counsel selected byLicensee for said preparation, filing, prosecution, and maintenance,OHSU shall promptly furnish copies of all patent-related documents toLicensee. |
| 7.02 | Each party shall promptly inform the other as to all matters that come to its attention that may affect the preparation, filing, prosecution, or maintenance of theLicensed Patent Rights and permit each other to provide comments and suggestions with respect to the preparation, filing, and prosecution ofLicensed Patent Rights, which comments and suggestions shall be considered by the other party. |
| 8.01 | Licensee agrees to keep accurate and correct records ofLicensed Products made, used, or sold andLicensed Processes practiced under thisAgreement appropriate to determine the amount of royalties dueOHSU.Licensee shall require its sublicensees to keep similar records so as to enableLicensee to audit any such sublicensees in order to meet its record keeping obligations under thisAgreement.Licensee’srecords shall be retained for at least three (3) years following a given reporting period.Licensee’s records shall be available during normal business hours for inspection at the expense ofOHSU by an accountant or other designated auditor selected byOHSU for the sole purpose of verifying reports and payments hereunder. The accountant or auditor shall only disclose toOHSU information relating to the accuracy of reports and payments made under thisAgreement. If an inspection shows an under reporting or underpayment in excess of five percent (5%) for any twelve (12) month period, thenLicensee shall reimburseOHSU for the cost of the inspection at the timeLicensee pays the unreported royalties, including any interest charges as required by Paragraph 6.10 of thisAgreement. All payments required under this Paragraph 8.01 shall be due within thirty (30) days of the dateOHSU providesLicensee notice of the payment due. |
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| 9. | REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS |
| 9.01 | Within ninety (90) days of the Effective Date of thisAgreement,Licensee shall provideOHSU with a written, executive summary of any currentDevelopment Planbeing used by Licensee, or, if applicable, with any exclusive sublicensee. |
| 9.02 | Licensee shall provide written annual reports on its product development progress or efforts to commercialize for each of theLicensed Fields of Use within sixty (60) days after December 31 of each calendar year. These progress reports shall include, but not be limited to, progress on research and development, status of applications for regulatory approvals, manufacturing, sublicensing, marketing, and sales during the preceding calendar year, strategic alliances with industry counterparts, as well as plans for the present calendar year.Licensee agrees to provide any additional data reasonably required byOHSU to evaluateLicensee’s performance. |
| 9.03 | Licensee shall report toOHSU the date of theFirst Commercial Sale of eachLicensed Product orLicensed Process in each country in theLicensed Territory within thirty (30) days of such occurrence. |
| 9.04 | Licensee shall submit toOHSU within sixty (60) days after each calendar half-year ending June 30 and December 31 a royalty report setting forth for the preceding half-year period the amount of theLicensed Products sold orLicensed Processes practiced by or on behalf ofLicensee or its sublicensees in each country within theLicensed Territory, theNet Sales, the milestones achieved, and the amount of royalty accordingly due. With each such royalty report;Licensee shall submit payment of the earned royalties due. If no earned royalties are due toOHSU for any reporting period, the written report shall so state. The royalty report shall be certified as correct by an authorized officer ofLicensee and shall include a detailed listing of all deductions made under Paragraph 2.09 to determineNet Sales made under Article 6 to determine royalties due. |
| 9.05 | Licensee agrees to forward semi-annually toOHSU a copy of such reports received byLicensee from its sublicensees during the preceding half-year period as shall be pertinent to a royalty accounting toOHSU byLicensee for activities under the sublicense. |
| 9.06 | All plans and reports required by this Article 9 and marked “Confidential” byLicensee shall be treated byOHSU as commercial and financial information obtained from a person, and as privileged and confidential and, to the extent permitted by the Oregon Public Records Law and other applicable laws, shall not be disclosed to any third party. |
| 10.01 | Licensee shall useReasonable Commercial Efforts to introduce theLicensed Products into the commercial market or apply theLicensed Processes to commercial use as soon as practicable. The efforts of a sublicensee shall be considered the efforts ofLicensee. |
| 10.02 | If and only to the extent applicable under 35 U.S.C. §200, upon theFirst Commercial Sale until the expiration of thisAgreement,Licensee shall useReasonable Commercial Efforts to keepLicensed Products andLicensed Processes reasonably accessible to the public. |
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| 11. | INFRINGEMENT AND PATENT ENFORCEMENT |
| 11.01 | OHSU andLicensee agree to notify each other promptly of each infringement or possible infringement, as well as any facts which may affect the validity, scope, or enforceability of theLicensed Patent Rights of which either party becomes aware. |
| 11.02 | Pursuant to thisAgreement and the provisions of Chapter 29 of Title 35, United States Code,Licensee may (a) bring suit in its own name, at its own expense, and on its own behalf for infringement of presumably valid claims in theLicensed Patent Rights; (b) in any such suit, enjoin infringement and collect for its use, damages, profits, and awards of whatever nature recoverable for such infringement; and (c) settle any claim or suit for infringement of theLicensed Patent Rights.Licensee shall take no action to compel.OHSU either to initiate or to join in any such suit for patent infringement.Licensee may requestOHSU to initiate or join any such suit if necessary to avoid dismissal of the suit. ShouldOHSU be made a party to any such suit,Licensee shall reimburseOHSU for any costs, expenses, or fees whichOHSU incurs as a result of such motion or other action, including any and all costs incurred byOHSU in opposing any such motion or other action. UponLicensee’s payment of all costs incurred byOHSU as a result ofLicensee’s joinder motion or other action, these actions byLicensee will not be considered a default in the performance of any material obligation under thisAgreement. In all cases,Licensee, agrees to keepOHSU reasonably apprised of the status and progress of any litigation. BeforeLicensee commences an infringement action or interference proceedings,Licensee shall notifyOHSU and give careful consideration to the views ofOHSU in deciding whether to bring suit. |
| 11.03 | In any infringement action or interference proceedings commenced under Paragraph 11.02, the expenses including costs, fees, attorney fees, and disbursements, shall be paid byLicensee. Up to [*] percent ([*]%) of such expenses may be credited against the royalties payable toOHSU under Paragraph 6.02 under theLicensed Patent Rights in the country in which such a suit is filed. In the event that [*] percent ([*]%) of such expenses exceed the amount of royalties payable byLicensee in any calendar year, the expenses in excess may be carried over as a credit on the same basis into succeeding calendar years. Any recovery made byLicensee, through court judgment or settlement, first shall be applied to reimburseOHSU for royalties withheld as a credit against litigation expenses and then to reimburseLicensee for its litigation expense. Any remaining recoveries shall be shared equally byLicensee andOHSU. |
| 11.04 | OHSU shall cooperate fully withLicensee in connection with an infringement action or interference proceedings initiated under Paragraph 11.02.OHSU agrees promptly to provide access to all necessary documents and to render reasonable assistance in response to a request byLicensee. |
| [*] | 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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| 11.05 | In the event that a declaratory judgment action alleging invalidity or non-infringement of any of theLicensed Patent Rights shall be brought againstLicensee or raised by way of counterclaim or affirmative defense in an infringement suit brought byLicensee under Paragraph 11.02, pursuant to thisAgreement and the provisions of Chapter 29 of Title 35, United States Code or other statutes,Licensee may a) defend the suit in its own name, at its own expense, and on its own behalf for presumably valid claims in theLicensed Patent Rights; b) in any such suit, ultimately to enjoin infringement and to collect for its use, damages, profits, and awards of whatever nature recoverable for such infringement; and c) settle any claim or suit for declaratory judgment involving theLicensed Patent Rights; provided, however, thatOHSU shall have the first right to take such actions and shall have a continuing right to intervene in such suit.Licensee shall take no action to compelOHSU either to initiate or to join in any such declaratory judgment action.Licensee may requestOHSU to initiate or join any such suit if necessary to avoid dismissal of the suit. ShouldOHSU be made a party to any such suit by motion or any other action ofLicensee,Licensee shall reimburseOHSU for any costs, expenses, or fees whichOHSU incurs as a result of such motion or other action. UponLicensee’s payment of all casts incurred byOHSU as a result ofLicensee’s joinder motion or other action, these actions byLicensee will not be considered a default in the performance of any material obligation under thisAgreement. IfLicensee elects not to defend against such declaratory judgment action,OHSU, at its option, may do so at its own expense. In all cases,Licensee agrees to keepOHSU reasonably apprized of the status and progress of any litigation. BeforeLicensee commences an infringement action,Licensee shall notifyOHSU and give careful consideration to the views ofOHSU in deciding whether to bring suit. |
| 12. | DISCLAIMER OF WARRANTIES AND INDEMNIFICATION |
| 12.01 | OHSU offers no warranties other than those specified in Article 1. |
| 12.02 | OHSU does not warrant the validity of theLicensed Patent Rights and makes no representations whatsoever with regard to the scope of theLicensed Patent Rights, or that theLicensed Patent Rights may be exploited without infringing other patents or other intellectual property rights of third parties. |
| 12.03 | OHSU MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THELICENSED PATENT RIGHTS. |
| 12.04 | OHSU does not represent that it will commence legal actions against third parties infringing theLicensed Patent Rights. |
| 12.05 | Licensee shall indemnify and hold OHSU, its directors, trustees, officers, employees, students, fellows, agents, and consultants harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage in connection with or arising out of a) the use by or on behalf of Licensee or sublicensees, directors, employees, or third parties of any Licensed |
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| | Patent Rights, or b) the design, manufacture, distribution, or use of anyLicensed Products,Licensed Processes or materials, or other products or processes developed in connection with or arising out of theLicensed Patent Rights, or c) otherwise arising out of exercise ofLicensed Patent Rights granted under thisAgreement.Licensee at all times shall carry insurance or self-insurance sufficient to cover its contractual obligations with respect to activities performed under thisAgreement.Licensee shall provide evidence of this coverage toOHSU. |
| 13. | TERM, TERMINATION, AND MODIFICATION OF RIGHTS |
| 13.01 | ThisAgreement is effective as of the effective date of theOriginal License Agreement and shall extend to the expiration of the last to expire of theLicensed Patent Rights unless sooner terminated as provided in this Article 13. |
| 13.02 | In the event thatLicensee is in default in the performance of any material obligations under thisAgreement, and if the default has not been remedied within sixty (60) days after the date of notice in writing of such default,OHSU may terminate thisAgreement by written notice. |
| 13.03 | Licensee may, upon sixty (60) days written notice toOHSU, terminate thisAgreement by doing all of the following: |
| | a) | Ceasing to make, have made, use, import, sell and offer for sale anyLicensed Products and/or use ofLicensed Processes; |
| | b) | Terminating all sublicenses, and causing all sublicensees to cease making, having made, using, importing, selling and offering for sale anyLicensed Products and/or use ofLicensed Processes; and |
| | c) | Paying all monies owed toOHSU under thisAgreement |
| 13.04 | OHSU shall specifically have the right to terminate thisAgreement ifOHSU determines that: 1)Licensee is more than thirty (30) days late in paying toOHSU any consideration due under thisAgreement andLicensee does not immediately payOHSU in full upon demand, 2)Licensee experiences aTrigger Event, or 3)Licensee breaches thisAgreement (other than a breach solely under 13.04 (1)1 and does not cure the breach within sixty (60) days after written notice of the breach. |
| | a) | OHSU shall specifically have the right to terminate or modify, at its option, thisAgreement, ifOHSU determines in good faith thatLicensee: 1) is not reasonably proceeding with the development and practical application (as such term is defined in 35 U.S.C. §201(f)) ofLicensed Products orLicensed Processes and theLicensee can not otherwise demonstrate toOHSU’s reasonable satisfaction that theLicensee has taken, or can be expected to take within a reasonable time, effective steps to achieve practical application of theLicensed Products orLicensed Processes; or 2) is not keepingLicensed Products orLicensed |
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| | Processes reasonably available to the public after commercial use commences. In making this determination,OHSU will take into account the normal course of such commercial development programs conducted with sound and reasonable business practices and judgment. Prior to invoking this right,OHSU shall give written notice toLicensee providingLicensee specific notice of, and a sixty (60) day opportunity to respond to,OHSU’s concerns as to the previous items 1) and 2). IfLicensee fails to alleviateOHSU’s concerns as to the previous items 1) and 2) or fails to initiate corrective action toOHSU’s satisfaction,OHSU may terminate or modify thisAgreement. |
| | b) | Notwithstanding Paragraph 13.05(a) above, ifLicensee has sublicensed its rights under this Agreement to a third party andOHSUhas approvedLicensee’s execution of such sublicense pursuant to Paragraph 4.01 of thisAgreement,Licensee and sublicensee shall be considered to be reasonably proceeding with development and practical application ofLicensed Products and otherwise complying with this Paragraph 13.05 while such sublicense agreement is in effect and not materially breached by sublicensee. |
| 13.06 | Within ninety (90) days of expiration or termination of thisAgreement under this Article 13, a final report shall be submitted byLicensee. Any royalty payments, including those related to patent expense, due toOHSU shall become immediately due and payable upon termination or expiration. If thisAgreement is terminated under this Article 13, sublicensees may elect to convert their sublicenses to direct licenses withOHSU pursuant to Paragraph 4.04. |
| 13.07 | Upon termination of thisAgreement, in the event that a sublicensee does not convert its sublicense to a direct license withOHSU pursuant to Paragraph 4.04,Licensee and any sublicensee shall, atOHSU’s request, return toOHSU any data provided or generated byOHSU to or forLicensee during the term of thisAgreement that will facilitate the development of theLicensed Patent Rights.Licensee will, and will cause its sublicensee who has not converted its sublicense to a direct license withOHSUto, negotiate in good faith withOHSU, or with any third party with whomOHSU is in confidential discussions for the license ofLicensed Patent Rightssubsequent to the termination of this Agreement,for the sale of any such data owned or controlled byLicensee and/or its sublicensee that will facilitate the development of theLicensed Patent Rights. |
| 13.08 | Upon termination of thisAgreement,Licensee shall cause physical inventories to be taken immediately of: (a) all completedLicensed Products or products requiring the use ofLicensed Processes on hand under the control ofLicensee or any sublicensee; and (b) suchLicensed Product(s) or products as are in the process of manufacture and component parts thereof as of the date of termination of thisAgreement, which inventories shall be reduced to writing.Licensee shall deliver copies of such written inventories, verified by an officer ofLicensee forthwith toOHSU.OHSU shall have 46 days after receipt of such verified inventories within which to challenge the inventory and request an audit. Upon five days written notice toLicensee,OHSU and its agents shall be given access during business hours to the premises ofLicensee or its sublicensees for |
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| | the purpose of conducting an audit. Upon the termination of thisAgreement,Licensee shall, at its own expense forthwith remove, efface or destroy all references toOHSU from all advertising or other materials used in the promotion ofLicensee’s business or the business of any sublicensee andLicensee and any sublicensee shall not thereafter represent in any manner that it has rights in or to theLicensed Patent Rights orLicensed Product(s) or products requiring the use ofLicensed Process(es). |
| 13.09 | Notwithstanding the foregoing, if thisAgreement terminates other than pursuant to Paragraph 13.04 1) or 2),Licensee shall have a period of six (6) months to sell off its inventory ofLicensed Product(s) or products requiring the use ofLicensed Process(es) existing on the date of termination of thisAgreement and shall pay royalties toOHSU with respect to suchLicensed Product(s) and products within thirty (30) days following the expiration of such six-month period (“Sell Off Right”). |
| 13.10 | Paragraphs 4.06, 6.06, 6.07, 8.01, 9.06, 12.01-12,05, 13.06-13.10, and 14.12 of thisAgreement shall survive termination of thisAgreement.Licensee’s obligation to pay all monies owed accruing under thisAgreement shall survive termination of thisAgreement. |
| 14.01 | Neither party may waive or release any of its rights or interests in thisAgreement except in writing. The failure ofOHSU to assert a right hereunder or to insist upon compliance with any term or condition of thisAgreement shall not constitute a waiver of that right byOHSU or excuse a similar subsequent failure to perform any such term or condition byLicensee. |
| 14.02 | ThisAgreement constitutes the entire agreement between the parties relating to the subject matter of theLicensed Patent Rights, and all prior negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by thisAgreement. |
| 14.03 | The provisions of thisAgreement are severable, and in the event that any provision of thisAgreement shall be determined to be invalid or unenforceable under any controlling body of law, such determination shall not in any way affect the validity or enforceability of the remaining provisions of thisAgreement. |
| 14.04 | If either party desires a modification to thisAgreement, the parties shall, upon reasonable notice of the proposed modification by the party desiring the change, confer in good faith to determine the desirability of such modification. No modification will be effective until a written amendment is signed by the signatories to thisAgreement or their designees. |
| 14.05 | The construction, validity, performance, and effect of thisAgreement shall be governed by the laws of the State of Oregon. |
| 14.06 | All notices required or permitted by thisAgreement shall be given by prepaid, first class, registered or certified mail properly addressed to the other party at the address designated on the following Signature Page, or to such other address as may be designated in writing by such other party, and shall be effective as of the date of the postmark of such notice. |
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| 14.07 | ThisAgreement shall not be assigned byLicensee except a) to an Affiliate, b) with the prior written consent ofOHSU, such consent not to be unreasonably withheld, and to be deemed given ifLicensee requestsOHSU’s consent andOHSU does not respond toLicensee’s request within sixty (60) days of said request; or c) as part of a sale or transfer of substantially the entire business ofLicensee relating to operations which concern thisAgreement.Licensee, shall notifyOHSU within ten (10) days of any assignment of thisAgreement byLicensee. |
| 14.08 | Licensee agrees in its use of anyOHSU-supplied materials to comply with all applicable statutes, regulations, and guidelines. |
| 14.09 | In connection with thisAgreement, the parties may provide to each other certain confidential information (“Confidential Information”). Each party agree to take customary steps to protect Confidential Information of the other party, including according such information the same policies and procedures applicable to its own confidential business information. Confidential Information will be disclosed to agents, employees, and sublicensees ofLicensee only on a “need-to-know” basis and only after such persons or companies have been informed of and obligated to maintain confidentiality. Each party will use the Confidential Information of the other only in connection with exercising its rights under thisAgreement. Confidential Information will not include information which is now or becomes part of the public domain through no fault of the receiving party, was already known by the receiving party at the time of disclosure by the disclosing party, was independently developed by the receiving party without use of Confidential Information of the other party, was obtained from a third party not under any confidentiality obligation with respect to such information, or was required to be disclosed by law, including the Oregon Public Records Law. |
| 14.10 | Licensee acknowledges that it is subject to and agrees to abide by the United States laws and regulations (including the Export Administration Act of 1979 and Arms Export Control Act) controlling the export of technical data, computer software, laboratory prototypes, biological material, and other commodities. The transfer of such items may require a license from the cognizant agency of theGovernment or written assurances byLicensee that it shall not export such items to certain foreign countries without prior approval of such agency.OHSU neither represents that a license is or is not required or that, if required, it shall be issued. |
| 14.11 | Licensee agrees to mark theLicensed Products or products requiring the use ofLicensed Processes or their packaging sold in the United States with all applicable U.S. patent numbers and similarly to indicate “Patent Pending” status. AllLicensed Products or products requiring the use ofLicensed Processes manufactured in, shipped to, or sold in other countries shall be marked in such a manner as to preserveOHSU patent rights in such countries. |
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| 14.12 | By entering into thisAgreement,OHSU does not directly or indirectly endorse any product or service provided, or to be provided, byLicensee whether directly or indirectly related to thisAgreement.Licensee shall not state or imply that thisAgreement is an endorsement byOHSU, or its employees. Additionally,Licensee shall not use the names ofOHSU or their employees in any advertising, promotional, or sales literature without the prior written consent ofOHSU. Either party may issue a press release regarding thisAgreement provided that the contents of said press release are mutually agreed to by the parties. |
| 14.13 | The parties agree to attempt to settle amicably any controversy or claim arising under thisAgreement or a breach of thisAgreement, including use of mediation. |
[SIGNATURES BEGIN ON NEXT PAGE.]
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OHSU PATENT LICENSE AGREEMENT EXCLUSIVE/EQUITY
SIGNATURE PAGE
| | | | | | |
| FOR OHSU: | | | | |
| | | |
| by: | | /s/ Arundeep S. Pradhan | | | | |
| | | | | | Date May 25, 2007 |
| Arundeep S. Pradhan | | | | |
| Director, Technology and Research | | | | |
| Collaborations, Oregon Health & Science University | | | | |
|
|
| Mailing Address for Notices: |
|
Technology and Research Collaborations, L335 |
Oregon Health & Science University |
2525 S.W. First Avenue, Suite 120 |
Portland, Oregon 97201 |
| | | | | | |
| | | |
| by: | | /s/ John P. Walker | | | | |
Signature of Authorized Official | | | | Date |
| | |
John P. Walker | | | | |
Printed Name | | | | |
| | |
Chairman-Interim CEO | | | | |
Title | | | | |
| | |
| Mailing Address for Notices: | | |
| |
601 Gateway Blvd., Suite 800 | | |
South San Francisco, Ca 94080 | | |
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APPENDIX A
Patent or Patent Application
PCT Patent Application #W0 99/49870 “Vitamin D and its Analogs in the Treatment of Tumors and Other Hyperproliferative Disorders.” Patent applications related to the pulsatile high-dose administration of Vitamin D and analogs in tumors and other hyperproliferative disorders, including, but not limited to, as follows:
| | | | | | | | | | | | | | |
| Matter ID | | Country | | Title | | Inventor | | Filing Date | | Application No. | | Issue Date | | Patent No. |
| [*] | | [*] | | [*] | | [*] | | [*] | | [*] | | [*] | | [*] |
| [*] | 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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APPENDIX B
Term Sheet
Included in Original License Agreement
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APPENDIX C
Investment Representation Letter
Included in Original License Agreement
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APPENDIX D
Stock Restriction Agreement
Included in Original License Agreement
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