Patent Assignment Agreement, dated September 12, 2010, between DelMar (BC) and Valent

A.  

Valent owns certain patent rights and related materials relating to [*] and the uses thereof.

B.  

The Parties have agreed to enter into this Agreement to record the terms on which Valent has agreed to assign, convey and transfer such patent rights and sell related materials to Del Mar.

(a)  

“Affiliate”, with respect to a Party, means any Person that, directly or indirectly through one or more intermediaries, controls, is controlled by, or is under common control with, such Party. A Person shall be regarded as in control of another Person if it owns or directly or indirectly controls more than fifty percent (50%) of the voting stock or other ownership interest of the other Person, or if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such Person.

(b)  

“Agreement” means this Patent Assignment Agreement, including all Schedules attached hereto.

(c)  

“Assigned Patents” means the patents and patent applications (and any patents to issue therefrom) that are identified on Schedule A attached hereto, and all patent applications (and the patents resulting therefrom) hereafter filed based upon or claiming priority from any such patents or patent applications, including any reissues, reexaminations, extensions (including any supplementary protection certificate), continuations, continuations in part (to the extent the claims thereof are supported by the specifications of patent applications otherwise included herein), divisions, provisionals, substitute applications, registration patents or patents of addition based on any such patent and all foreign counterparts of any of the foregoing.

(d)  

“Business Day” means any day other than Saturday, Sunday or other Days on which commercial banks in Vancouver, British Columbia, Canada or California, USA are authorized or required by law or executive order to close.

(e)  

“Calendar Quarter” means a period of three months ending on March 31, June 30, September 30 and December 31 in each Calendar Year.

(f)  

“Calendar Year” means a period of one year ending on December 31.

(g)  

“Compound” means any of the following: [*]

(h)  

“Days” means any day, including working days, public holidays and weekend days.

(i)  

“Del Mar Shares” means voting common shares of Del Mar.

(j)  

“Diligent Efforts” means, with respect to Del Mar, the use of reasonable, diligent, good faith efforts and resources, as commonly used in the biotechnology industry by a company of similar resources as Del Mar for a product discovered or identified internally, which product is at a similar stage in its development or product life and is of similar market potential.  Diligent Efforts requires that Del Mar (itself or through its Affiliates or Third Party licensees), at a minimum, assign responsibility for such obligations to qualified employees, contractors or consultants, set annual goals and objectives for carrying out such obligations, and allocate resources designed to advance such goals and objectives.

(k)  

“EMEA” means the European Medicines Agency, and any successor thereof.

(l)  

“FDA” means the United States Food and Drug Administration, and any successor thereof.

(m)  

“Financing Transaction” means a cumulative equity or debt financing(s), or a merger, acquisition, amalgamation, reverse takeover or other combination, or any combination of the foregoing, cumulatively totalling at least USD $2,000,000.

(n)  

“First Commercial Sale” means, on a country by country basis, with respect to a Product, the first bona fide sale of such Product to a Third Party by or on behalf of Del Mar, its Affiliates or licensees in a country in the Territory after Regulatory Approval has been achieved for such Product in such country.  For greater certainty, sales for test marketing, sampling and promotional uses, clinical trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale, so long as the Product is provided free of charge, or at or below cost.

(o)  

“Formalities” has the meaning given to it in Section 2.3.

(p)  

“Generic Competition” means, with respect to a Product in a country, that another product(s) competitive with such Product and containing a Compound as its active ingredient is being lawfully marketed and sold by a Third Party in such country at the applicable time, and such competitive product(s) is approved for the same use as the Product, and such competitive product(s) (in units sold) in the applicable Calendar Quarter for such country exceeds 10%  of the total aggregate sales (in units sold) of such competitive product(s) combined with sales of such Product during such Calendar Quarter (based on sales statistics compiled by the government of the country, or by an organization the compiles such information and is acceptable to the Parties).

(q)  

“Indemnified Party” has the meaning given to it in Section 9.3.

(r)  

“Indemnifying Party” has the meaning given to it in Section 9.3.

(s)  

“IP” means intellectual property of all types, including, without limitation, patents, copyrights, trademarks, service marks, trade dress, trade secrets, know-how, technology, data, and inventions (whether patented or not), data exclusivity, orphan drug exclusivity and other marketing exclusivity, and registrations and applications for registration of the foregoing.

(t)  

“Licensing Revenues” means all remuneration received by Del Mar and its Affiliates from Third Party licensees with respect to the development or commercialization of Products, including (i) royalties (whether prepaid, advance or running) based on sales of Products by Third Party licensees or their sublicensees; (ii) any licensing fees for rights to develop or commercialize Products, or other payments in connection with the licensing of rights with respect to Products, the Assigned Patents or Materials; (iii) milestone payments based on development, regulatory or commercialization milestones for Products; but excluding  (A) equity purchases of Del Mar securities to the extent not exceeding the fair market value of such securities; and (B) equity, credit, barter, benefit, advantage, concession or amounts paid by the Third Party licensees or other collaborators or funders as advance payment or reimbursement for contract research and development activities.  If Del Mar and its Affiliates accept any form of consideration other than monies in lieu of such payments from Third Party licensees, such consideration will be converted into an equivalent monetary value, and such monetary value will be considered Licensing Revenues to Del Mar and its Affiliates under this Agreement.  “Licensing Revenues” exclude all Net Sales received by Del Mar and its Affiliates.

(u)  

“Losses” means all losses, obligations, liabilities, damages, costs and expenses, including reasonable attorney’s fees.

(v)  

“Materials” means the following in the possession or under the control of Valent and its Affiliates as of the Effective Date: (i) any samples or stock of the Compounds and/or Products (the “Prototype Drug”); (ii) prosecution files and associated docket list for the Assigned Patents; and (iii) IP, regulatory filings, results, data and other related materials related to the development, manufacture and/or commercialization of the Products.

(w)  

“Net Sales” means, for any period, the gross amount invoiced by Del Mar and its Affiliates for the sale of Products to Third Parties, (including, without limitation, Third Party agents, distributors and wholesalers), less the total of the following, to the extent actually included in such invoiced amount and specifically applicable to the sale of such Products:

(i)  

trade, cash and/or quantity discounts not already reflected in the amount invoiced;

(ii)  

all excise, sales and other consumption taxes (including VAT) and custom duties, whether or not specifically identified as such in the invoice to the Third Party;

(iii)  

freight, distribution, insurance and other transportation charges, whether or not specifically identified as such in the invoice to the Third Party;

(iv)  

amounts repaid or credited by reason of rejections, defects or returns or because of chargebacks, retroactive price reductions, refunds or billing errors; and

(v)  

rebates and similar payments made with respect to sales paid for or reimbursed by any governmental or regulatory authority such as, by way of illustration and not in limitation of the Parties’ rights hereunder, United States Federal or state Medicaid, Medicare or similar state program or equivalent foreign governmental program.

(x)  

“Patent Prosecution Consultation Period” has the meaning given to it in Section 6.2.

“Person” means any individual, corporation, partnership, association, joint-stock company, trust, unincorporated organization or government or political subdivision thereof.

(z)  

“Products” means any and all products (i) containing or comprising a Compound as an active ingredient, or (ii) covered by or derived from any Valid Claims.

(aa)  

“Reacquisition Option” has the meaning given to it in Section 3.1.

(bb)  

“Reacquisition Option Period” has the meaning given to it in Section 3.1.

(cc)  

“Reacquisition Trigger Date” has the meaning given to it in Section 3.1.

(dd)  

“Regulatory Approval” means, with respect to any country, any and all approvals (including any applicable governmental price and reimbursement approvals), licenses, registrations, or authorizations of any Regulatory Authority necessary for the manufacture, use, storage, import, transport, promotion, marketing and commercial sale (including without limitation, packaging and labelling) of Products for human or animal use (as the case may be) in the country.

(ee)  

“Regulatory Authority” means, with respect to any country, any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority to grant a Regulatory Approval or having jurisdiction over the testing, manufacture, use, storage, import, transport, promotion, marketing and sale of Products for human or animal use (as the case may be) in the country, including, in the United States, the FDA and in the European Union, the EMEA.

(ff)  

“Regulatory Exclusivity Period” means, with respect to each Product, the period that any Regulatory Authority prohibits approval of another product competitive with the Product from being lawfully marketed and sold by a Third Party in a country.

(gg)  

“Royalty Term” means, with respect to each Product, on a country by country basis in each country within the Territory, commencing on the First Commercial Sale of the Product until the last of:

(i)  

the expiration of the last to expire of the Valid Claims in the Assigned Patents covering such Product in such country;

(ii)  

the expiration of any Regulatory Exclusivity Period covering such Product in such country; and

(iii)  

ten (10) years.

(hh)  

“Territory” means worldwide.

(ii)  

“Third Party” means any Person other than a Party or an Affiliate of any Party to this Agreement.

(jj)  

“US” means the United States of America, and its territories and possessions.

(kk)  

“USD” or “US Dollars” means the legal tender (currency) in the United States of America.

(ll)  

“Valid Claim” means a claim (i) of an issued and unexpired Assigned Patent that has not been revoked or held permanently unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through re-issue or disclaimer or otherwise, or (ii) of any patent application included in the Assigned Patents that has not been cancelled, withdrawn or abandoned or been pending for more than six (6) years.

(a)  

If Del Mar elects not to proceed (“Opts-Out”) with the research, development and commercialization of the Products conducted by itself or its Affiliates or through Third Party licensees, then Del Mar will give written notice thereof (an “Opt-Out Notice”) to Valent.  In addition, if Del Mar materially breaches its obligations under Section 2.5, then Valent shall have the right to give Del Mar written notice of reversion (a “Reversion Notice”), provided that in such event, the Reversion Notice shall not become effective if Del Mar, within thirty (30) days after receiving such Reversion Notice: (i) cures such breach, or, (ii) if such breach is not curable within such thirty (30)-day period, provides Valent with a reasonable plan to cure such breach in a form that is reasonably acceptable to Valent, further provided that Valent shall have the right to provide Del Mar with another Reversion Notice effective immediately if Del Mar does not perform according to such plan.  Effective as of the effective date of the Opt-Out Notice or Reversion Notice, as the case may be, (i) Del Mar hereby assigns, conveys and transfers to Valent at no cost to Valent (A) all Del Mar’s then existing right, title and interest in and to the Assigned Patents and Materials; and (B) all know-how, regulatory filings, results, data and other related materials related to the development, manufacture and/or commercialization of the Products that are generated or otherwise obtained by or on behalf of Del Mar, its Affiliates or licensees and that Del Mar has the right to so transfer, assign and convey to Valent without violating any other agreement or arrangement with any Third Party; and (ii) Del Mar hereby grants Valent a non-exclusive, fully-paid, royalty-free, perpetual, worldwide and non-transferable (except as provided in Section 11.1) license, with the right to grant sublicenses, under all IP controlled by Del Mar that is incorporated into the Products and that Del Mar has the right to so license to Valent without violating any other agreement or arrangement with any Third Party, to develop, make, have made, use, offer for sale, sell and import the Products.

(b)  

Upon the effective date of the Opt-Out Notice or Reversion Notice, as the case may be, Valent shall have sole discretion and responsibility (but not the obligation), at its cost, for the research, development and commercialization of the Products; however, Valent shall pay Del Mar royalties on the annual worldwide Valent Net Sales of Products.  The royalty rate shall be based on the stage of development and commercialization that the Products had achieved at the effective date of the Opt-Out Notice or Reversion Notice, as follows:

Prior to acceptance of an IND

Prior to Commencement of the first Registration Trial

After Commencement of the first Registration Trial

(c)  

For the purposes of this Section 2.6, the following terms will have the following meanings:

(i)  

trade, cash and/or quantity discounts not already reflected in the amount invoiced;

(ii)  

all excise, sales and other consumption taxes (including VAT) and custom duties, whether or not specifically identified as such in the invoice to the Third Party;

(iii)  

freight, distribution, insurance and other transportation charges, whether or not specifically identified as such in the invoice to the Third Party;

(iv)  

amounts repaid or credited by reason of rejections, defects or returns or because of chargebacks, retroactive price reductions, refunds or billing errors; and

(v)  

rebates and similar payments made with respect to sales paid for or reimbursed by any governmental or regulatory authority such as, by way of illustration and not in limitation of the Parties’ rights hereunder, United States Federal or state Medicaid, Medicare or similar state program or equivalent foreign governmental program.

(a)  

Generic Competition.  If, in a given country during a Calendar Quarter for which royalties are being calculated hereunder for Net Sales, any Product is not covered by a Valid Claim included in the Assigned Patents or by any Regulatory Exclusivity Period AND Generic Competition exists for the particular Product(s) in such country, then the royalty rate otherwise applicable to the Net Sales will be reduced by fifty percent (50%) (i.e., reduced to five percent (5%)).

(b)  

Anti-Stacking Provision.  If access to a Third Party’s IP is required for exploitation of the Products, and in such circumstances Del Mar or its Affiliates pay royalties to a Third Party for any Product for which royalties are also due to Valent for Net Sales, Del Mar will have the right to deduct from the royalties owed to Valent on account of Net Sales fifty percent (50%) of the royalties paid to such Third Party for such Product, provided that this reduction in payment to Valent will not exceed five percentage points (5%) of the ten percent (10%) royalties on Net Sales otherwise payable by Del Mar to Valent (i.e., the royalty payable to Valent will be reduced by up to five percent (5%)).

(a)  

Record Retention.  Del Mar will maintain (and will ensure that its Affiliates will maintain) complete and accurate books, records and accounts that fairly reflect their respective Net Sales and Licensing Revenues in sufficient detail to confirm the accuracy of any payments required hereunder, which books, records and accounts will be retained by Del Mar until the longer of three (3) years after the end of the period to which such books, records and accounts pertain or any retention period under applicable law.

(b)  

Audit.  Valent will have the right to have an independent chartered accounting firm of nationally recognized standing, reasonably acceptable to Del Mar, to have access during normal business hours, and upon reasonable prior written notice, to such of the records of Del Mar and its Affiliates as may be reasonably necessary to verify the accuracy of such Net Sales and Licensing Revenues for any Calendar Year ending not more than thirty-six (36) months prior to the date of such request; provided, however, that Valent will not have the right to conduct more than one such audit in any twelve (12)-month period unless any prior audit reveals a material misstatement or misrepresentation by Del Mar in its reporting, accounting or record keeping of Net Sales or Licensing Revenues pursuant to this Agreement, in which case Valent may conduct subsequent additional audit(s) in the same (12)-month period in order to verify that the misstatement or misrepresentation has been corrected.  The accounting firm will disclose to each Party whether such Net Sales and Licensing Revenues, as applicable, are correct or incorrect and the specific details concerning any discrepancies.  No other information will be provided to Valent.  Valent will bear the cost of such audit unless the audit reveals a variance of more than five percent (5%) from the reported results, in which case Del Mar will bear the reasonable cost of the audit.  The results of such accounting firm will be final, absent manifest error.

(c)  

Payment of Additional Royalties.  If, based on the results of such audit, additional payments are owed by Del Mar under this Agreement, Del Mar will make such additional payments, within forty-five (45) days after the date on which such accounting firm’s written report is delivered to Del Mar.

(d)  

Confidentiality.  Valent will treat all information subject to review under Section 4.10 in accordance with the confidentiality provisions of Article 5 and will cause its accounting firm to enter into a reasonably acceptable confidentiality agreement with Del Mar obligating such firm to maintain all such financial information in confidence pursuant to such confidentiality agreement.

(a)  

to its Affiliates and their respective directors, shareholders, employees and consultants who have a need to know, each of whom prior to disclosure must be bound by obligations of confidentiality at least equivalent in scope to those set forth in this Article 5,

(b)  

if required by applicable law, regulation or stock exchange regulation, provided, however, that the disclosing Party shall (i) provide the other Party with reasonable advance notice of and an opportunity to comment on any such required disclosure, (ii) if requested by such other Party, seek confidential treatment with respect to any such disclosure to the extent available, and (iii) use good faith efforts to incorporate the comments of such other Party in any such disclosure or request for confidential treatment;

(c)  

to the extent needed to disclose to any Third Party actual or potential shareholders, lenders, licensees or licensors, sub-contractors, customers, acquirers or merger candidates; existing or potential pharmaceutical collaborators; investment bankers; existing or potential investors, venture capital firms or other financial institutions or investors for purposes of obtaining financing, each of whom prior to disclosure must be bound by a duty of non-disclosure; or

(d)  

in the case of Del Mar, to any Regulatory Authority as required in connection with any filing, application or request for Regulatory Approval for Products; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information.

(a)  

Valent is the sole and exclusive owner of all right, title and interest in and to the Materials;

(b)  

Valent is the sole and exclusive owner of all right, title and interest in and to the Assigned Patents;

(c)  

the Assigned Patents identified on Schedule A include all patents and patent applications owned by Valent or its Affiliates on or prior to the Effective Date that cover 1,2,5,6-Dianhydrogalactitol.  There are no other US or unpublished foreign filings owned or controlled by Valent or its Affiliates filed prior to the Effective Date  that cover 1,2,5,6-Dianhydrogalactitol and uses thereof other than as set forth on Schedule A, nor does Valent have any intention to make any such filing;

(d)  

Valent has the right to transfer to Del Mar good and clear title to the Assigned Patents and Materials free and clear of all claims, liens and encumbrances;

(e)  

Valent is not a party to or threatened with any legal proceedings, claims or enquiries relating to the Assigned Patents or the Materials, and is not aware of any circumstances which would give rise to any such legal proceedings or enquiries;

(f)  

Valent has timely made all filings, payments of fees and recordations with the applicable intellectual property or patent offices as required by applicable laws to maintain its interest in the Assigned Patents as set out on Schedule A, and all such registrations and applications remain in full force and effect and have not been abandoned or withdrawn;

(g)  

to Valent’s best knowledge, the Assigned Patents set out on Schedule A list all inventors and owners of the Assigned Patents set out on Schedule A in accordance with applicable laws;

(h)  

Valent has used commercially reasonable efforts to protect the secrecy of all confidential Materials;

(i)  

Valent and its Affiliates have not assigned, charged or encumbered, or agreed to assign, charge or encumber, the Assigned Patents or the Materials;

(j)  

Valent and its Affiliates have not granted, or agreed to grant, a license, in any form, for all or any portion of the Assigned Patents or the Materials;

(k)  

Valent has made full and complete disclosure to Del Mar of all material facts and information that Valent has in its possession concerning any circumstances that could adversely affect in a material manner the proposed development, production or disposition of Products by Del Mar;

(l)  

neither the execution and delivery of this Agreement, nor the completion of the purchase and sale contemplated herein will:

(i)  

violate any of the terms and provisions of the constating documents of Valent, or any order, decree, statute, bylaw, regulation, covenant or restriction applicable to Valent, the Assigned Patens or Materials; or

(ii)  

give any person the right to acquire, deal with or obtain any interest or right in any of the Assigned Patents or Materials; and

(m)  

the summary of the existing Assigned Patents set out in Schedule A is true and correct in all material respects.

(a)  

the Indemnifying Party may so assume the defense of any such claim or any litigation resulting therefrom only if it shall give notice to the Indemnified Party of the Indemnifying Party’s decision to so assume such defense within thirty (30) Days after the date of the notice from the Indemnified Party of the Third Party claim as to which indemnity is sought and acknowledges in writing to the Indemnified Party that any Losses in connection with such claim or any litigation resulting therefrom are Losses for which the Indemnified Party shall be entitled to indemnification pursuant to this Agreement;

(b)  

counsel for the Indemnifying Party, who shall conduct the defense of such claim or any litigation resulting therefrom (if such defense is assumed by the Indemnifying Party), shall be approved by the Indemnified Party (whose approval shall not be unreasonably withheld) and the Indemnified Party may participate in such defense with the Indemnified Party’s own counsel at the Indemnified Party’s own expense (unless (i) the employment of counsel by such Indemnified Party has been authorized by the Indemnifying Party; (ii) the Indemnified Party shall have reasonably concluded that there may be a conflict of interest between the Indemnifying Party and the Indemnified Party in the defense of such action; or (iii) the Indemnifying Party shall have failed to assume the defense as provided herein, in each of which cases the Indemnifying Party shall pay the reasonable fees and expenses of one law firm serving as counsel for the Indemnified Party, which law firm shall be subject to approval, not to be unreasonably withheld, by the Indemnifying Party);

(c)  

the failure of any Indemnified Party to give notice as provided herein shall not relieve the Indemnifying Party of its obligations under this Agreement to the extent that the failure to give notice did not result in prejudice to the Indemnifying Party;

(d)  

no Indemnifying Party, in the defense of any such claim or litigation, shall, except with the approval of each Indemnified Party, which approval shall not be unreasonably withheld, consent to entry of any judgment or enter into any settlement which (i) would result in injunctive or other relief being imposed against the Indemnified Party; or (ii) does not include as an unconditional term thereof the giving by the claimant or plaintiff to such Indemnified Party of a release from all liability in respect to such claim or litigation;

(e)  

each Indemnified Party shall furnish such information regarding itself or the claim in question as an Indemnifying Party may reasonably request in writing and shall be reasonably required in connection with the defense of such claim and litigation resulting therefrom; and

(f)  

if the Indemnifying Party assumes the defense of the Third Party claim or litigation, the Indemnified Party shall not settle or agree to a judgment with respect to such claim or litigation without the consent of the Indemnifying Party.

(a)  

In the event that Del Mar breaches its payment obligations under this Agreement, Valent may immediately terminate this Agreement in the event that Del Mar has not remedied such breach within sixty (60) Days after Valent sends written notice specifying such breach to Del Mar.

(b)  

Except as provided above in Section 10.2(a), either Party may at its sole discretion unilaterally terminate this Agreement in the event that the other Party materially breaches any of its obligations under this Agreement and does not cure such breach within thirty (30) Days after receipt of notice thereof.

(a)  

In the event that Valent terminates this Agreement as provided above in Section 10.2(a), then effective as of the effective date of such termination, (i) Del Mar hereby assigns, conveys and transfers to Valent at no cost to Valent (A) all Del Mar’s then existing right, title and interest in and to the Assigned Patents and Materials; and (B) all know-how, regulatory filings, results, data and other related materials related to the development, manufacture and/or commercialization of the Products that are generated or otherwise obtained by or on behalf of Del Mar, its Affiliates or licensees and that Del Mar has the right to so transfer, assign and convey to Valent without violating any other agreement or arrangement with any Third Party; and (ii) Del Mar hereby grants Valent a non-exclusive, fully-paid, royalty-free, perpetual, worldwide and non-transferable (except as provided in Section 11.1) license, with the right to grant sublicenses, under all IP controlled by Del Mar that is incorporated into the Products and that Del Mar has the right to so license to Valent without violating any other agreement or arrangement with any Third Party, to develop, make, have made, use, offer for sale, sell and import the Products.

(b)  

Except as provided in Section 10.3(a), termination or expiration of this Agreement for any reason will not result in any right, title or interest in or to the Assigned Patents and Materials revesting in Valent, all of which shall remain the property of Del Mar; provided, however, following such termination or expiration of this Agreement Del Mar shall continue to be obligated to pay to Valent royalties on Net Sales and Licensing Revenues subject to and in accordance with the terms and conditions of this Agreement.

(c)  

Termination of this Agreement for any reason shall not affect or impair the terminating Party’s right to pursue any legal remedy, subject to the terms of this Agreement, including, but not limited to, the right to recover damages, for any harm suffered or incurred by the terminating Party as a result of such breach or default.

(d)  

Article 4, Article 5, Article 8, and Article 9, and Sections 10.3, 11.9, and such other provisions as may reasonably be expected to remain in force will survive the expiration or termination of this Agreement and will remain in full force and effect following such expiration or termination.

(a)  

If to Valent, at:

(b)  

If to Del Mar, at: