EX-10.26 25 d804420dex1026.htm EX-10.26 [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act...
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
Exhibit 10.26
This License Agreement (this “Agreement”) is made effective as of June 20, 2012 (the “Effective Date”) by and between Karagen Pharmaceuticals, Inc., a Maryland close corporation with a principal place of business at 0 Xxxx Xxxx, Xxxxxxxxx, Xxxxxxxx 00000 (“Licensor”), and Aduro BioTech, Inc. (“Licensee”), a Delaware corporation with a place of business at 000 Xxxxxxxx Xxx, Xxxxxxxx, XX 00000. Licensor and Licensee are each hereafter referred to individually as a “Party” and together as the “Parties”.
WHEREAS, Licensor has represented to Licensee that Licensor has entered into a license agreement (the “Preexisting License”) with a Third Party (“Preexisting Licensee”) for non-exclusive rights with an option to convert its current licensed rights in the Product Rights, all of which are nonexclusive, to exclusive with regard to one or more infectious diseases on a disease-by-disease basis (the “Preexisting Options”)) on the terms as they exist on the date hereof and specifically described in Exhibit A hereto (“Preexisting Rights”);
Whenever used in the Agreement with an initial capital letter, the terms defined in this Article 1 shall have the meanings specified.
1.1 “Affiliate” shall mean any corporation, firm, limited liability company, partnership or other entity that directly controls or is controlled by or is under common control with a Party to this Agreement. For purposes of this Section 1.1, “control” means ownership, directly or indirectly through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent
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(50%) or more of the equity interests in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or equivalent governing body of a corporation or other entity.
1.2 “BLA” shall mean a biologics license application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed with the FDA seeking Regulatory Approval to market and sell any Licensed Product in the United States for a particular indication within the Exclusive Licensed Field or Non-Exclusive Licensed Field.
1.3 “Confidential Information” shall mean with respect to a Party (the “Receiving Party”), all information that is disclosed or has been previously disclosed by the other Party (the “Disclosing Party”) to the Receiving Party hereunder or to any of its Affiliates or its or their directors, officers, employees, or agents, except to the extent that the Receiving Party can demonstrate by written record or other suitable physical evidence that such information, (a) as of the date of disclosure is demonstrably known to the Receiving Party or its Affiliates other than by virtue of a prior confidential disclosure to such Party or its Affiliates; (b) as of the date of disclosure is in, or subsequently enters, the public domain, through no fault or omission of the Receiving Party; (c) is obtained from a Third Party having a lawful right to make such disclosure free from any obligation of confidentiality to the Disclosing Party; or (d) is independently developed by or for the Receiving Party without reference to or reliance upon any Confidential Information of the Disclosing Party.
1.4 “Control” or “Controlled” shall mean with respect to any Patent Rights or Technology, the possession by a Party of the ability to grant a license or sublicense of such Patent Rights or Technology as provided for herein without violating the terms of any arrangement or agreements written or otherwise between such Party and any Third Party or without requiring such Party to make undue payment to any Third Party.
1.5 “Drug Approval Application” shall mean any application for Regulatory Approval (including pricing and reimbursement approvals) required prior to any commercial sale or use of a Licensed Product in any country or jurisdiction in the Territory, including, without limitation, (a) any BLA or MAA filed with the FDA or any Foreign Regulatory Authority, and (b) any equivalent application filed with any Foreign Regulatory Authority for Regulatory Approval (including pricing and reimbursement approvals) required prior to any commercial sale or use of a Licensed Product in any country or jurisdiction in the Territory.
1.6 “Exclusive Licensed Field” shall mean human medical and veterinary uses of a Licensed Product for therapeutic and/or prophylactic treatment of cancer or precancerous conditions. For the sake of clarity, this Exclusive Licensed Field includes the therapeutic and/or prophylactic treatment of cancer or precancerous conditions caused by infectious agents, but excludes therapeutic and/or prophylactic treatment of the infectious agent itself. For example, the Exclusive Licensed Field includes the prevention and treatment of cervical cancer in humans, but does not include the treatment of human papilloma virus.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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1.7 “FDA” shall mean the United States Food and Drug Administration and any successor agency or authority thereto.
1.8 “First Commercial Sale” shall mean, on a country-by-country basis, the date of the first arm’s length sale to a Third Party of a Licensed Product by or on behalf of Licensee or any Affiliate or Sublicensee of Licensee in such country as part of a coordinated country-wide commercialization effort.
1.9 “Foreign Regulatory Authorities” shall mean any applicable supranational, national, federal, state or local regulatory agency, department, bureau or other governmental entity of any country or jurisdiction in the Territory (other than the FDA in the United States), having responsibility in such country or jurisdiction for any Regulatory Approvals of any kind in such country or jurisdiction, and any successor agency or authority thereto.
1.10 “ID” shall mean infectious disease.
1.11 “Improvements” shall mean any enhancement, invention or discovery created or identified by Licensor during the Term that constitutes an improvement to the Licensed Patent Rights or Licensed Technology to their subject matter.
1.12 “IND” shall mean an investigational new drug application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time) filed or to be filed with the FDA with regard to any Licensed Product.
1.13 “Licensed Patent Rights” means all Patent Rights relating to the Exclusive License Field or the Nonexclusive License Field that are Controlled by Licensor as of the Effective Date or become Controlled by Licensor during the Term, to the extent reasonably necessary or useful for the manufacture, use or sale of the Licensed Products. The Licensed Patent Rights as of the Effective Date are listed in Exhibit B, attached hereto and made a part hereof. Exhibit B shall be updated by Licensor by written notice to Licensee on an annual basis during the Term to include any additional patents and patent applications not previously listed; however, the inclusion or exclusion of a patent or patent application from Exhibit B is not to be deemed a conclusive indication of whether that patent or application is or should be considered a “Licensed Patent Right” for purposes of this Agreement.
1.14 “Licensed Product” shall mean any product, the making, using, selling, importing or providing a service the conduct of which would, absent the license granted to Licensee hereunder, infringe any Valid Claim included in the Licensed Patent Rights.
1.15 “Licensed Technology” shall mean and include all Technology, whether or not patentable, including but not limited to formulations, techniques and materials, Controlled by Licensor as of the Effective Date or that becomes Controlled by Licensor during the Term that (a) is related to any patent or patent application included in the Licensed Patent Rights or (b) is reasonably necessary or useful for Licensee to practice the license granted to it hereunder.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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1.16 “License Term” shall mean, with respect to each Licensed Product, the period commencing on the Effective Date and continuing on a country-by-country basis until the last to expire of the Licensed Patent Rights covering the Licensed Product in each country.
1.17 “MAA” shall mean an application filed with the relevant Foreign Regulatory Authorities in Europe seeking Regulatory Approval to market and sell any Licensed Product in Europe or any country or territory therein for a particular indication within the Exclusive Licensed Field or Non-Exclusive Licensed Field.
1.18 “Net Sales” shall mean the amounts invoiced for all Licensed Products sold by Licensee and Affiliates and Sublicensees to Third Parties throughout the Territory during each calendar quarter, less the following deductions, exclusions and other amounts incurred or paid by Licensee or its Affiliates or Sublicensees with respect to sales of Licensed Products regardless of the calendar quarter in which such sales were made, provided that should sales not be sufficient to cover deductions such deductions may be carried to following calendar quarters:
(a) trade, cash and quantity discounts or rebates actually allowed or taken including, without limitation, discounts or rebates to governmental or managed care organizations;
(b) credits or allowances actually given or made for rejection or return of previously sold Licensed Products (including Medicare and similar types of rebates) and amounts attributable to uncollectible and bad accounts;
(c) any charges for insurance, freight, and other transportation costs directly related to the delivery of Licensed Product to the extent included in the gross invoiced sales price;
(d) any tax, tariff, duty or governmental charge levied on the sales, transfer, transportation or delivery of a Licensed Product (including any tax such as a value added or similar tax or government charge) borne by the seller thereof, other than franchise or income tax; and
(e) any import or export duties or their equivalent borne by the seller.
“Net Sales” shall not include (i) intermediate sales or transfers of Licensed Product between Licensee and its Affiliates or Sublicensees that are not arm’s length transactions, (ii) samples or quantities of Licensed Product used for access or assistance programs; (iii) Licensed Product used in preclinical and clinical trials or other research, and (iv) charitable and compassionate uses of Licensed Product or product tenders.
If Licensed Product is ever bundled with other products or equipment, in order to determine the portion of the sales price for the bundle that should be allocated to “Net Sales”, the Parties shall approve a formula that accurately determines the portion of the sales price for the bundle that reflects the fair market value of the Licensed Product when compared to the sum of the fair market value of all products in the bundle, based on the fair market value of a product when it is sold separately in the relevant sales channel and jurisdiction.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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1.19 “Non-Exclusive Licensed Field” shall mean all human medical and veterinary uses of Licensed Product other than those used in the Exclusive Licensed Field.
1.20 “Option Subfield” shall mean a Subfield designated by Licensee within the Non-Exclusive Licensed Field for inclusion within the Exclusive Licensed Field.
1.21 “Patent Rights” shall mean the rights and interests in and to issued patents and pending patent applications (including inventor’s certificates and utility models) in any country or jurisdiction within the Territory, including all provisionals, substitutions, continuations, continuations-in-part, divisionals, supplementary protection certificates, renewals, all letters patent granted thereon, and all reissues, reexaminations, extensions, confirmations, revalidations, registrations, patents of addition thereof, PCTs, foreign counterparts, and industrial rights Controlled by a Party.
1.22 “Phase II Clinical Study” shall mean, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety, dose ranging and efficacy of such Licensed Product for such indication, that is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial of such Licensed Product for such indication.
1.23 “Phase III Clinical Trial” shall mean, as to a particular Licensed Product for a particular indication, a controlled and lawful study in humans of the safety and efficacy of such Licensed Product for such indication, that is prospectively designed to demonstrate statistically whether such Licensed Product is safe and effective for use in such indication in a manner sufficient to file a BLA to obtain Regulatory Approval to market and sell that Licensed Product in the United States for the indication under investigation in such study.
1.24 “Regulatory Approval” shall mean any and all approvals (including pricing and reimbursement approvals), product and establishment licenses, registrations or authorizations of any kind of the FDA or any Foreign Regulatory Authority necessary for the development, pre-clinical and/or human clinical testing, manufacture, quality testing, supply, use, storage, importation, export, transport, marketing and sale of a Licensed Product (or any component thereof) for use in the Exclusive Licensed Field or Non-Exclusive Licensed Field in any country or other jurisdiction in the Territory. “Regulatory Approval” shall include, without limitation, any BLA, MAA or other Drug Approval Application.
1.25 “Subfield” shall mean a disease or condition, or set of related diseases or conditions, for which Regulatory Approval can be sought for a Licensed Product. For instance, “autoimmune disorders” and “metabolic disorders and obesity, and related disorders” are both Subfields.
1.26 “Sublicensee” shall mean any Third Party to whom Licensee grants a sublicense of some or all of the rights granted to Licensee under this Agreement.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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1.27 “Technology” shall mean and include any and all unpatented, proprietary ideas, inventions, discoveries, Confidential Information, biologic materials, data, results, formulae, designs, specifications, methods, processes, formulations, techniques, ideas, know-how, technical information (including, without limitation, structural and functional information), process information, pre-clinical information, clinical information, and any and all proprietary biological, chemical, pharmacological, toxicological, pre-clinical, clinical, assay, control and manufacturing data and materials.
1.28 “Term” shall have the definition set forth in Section 9.1.
1.29 “Territory” shall mean worldwide.
1.30 “Third Party” shall mean any person or entity other than Licensee, Licensor and their respective Affiliates.
1.31 “Valid Claim” shall mean those claims of a patent or patent application in any country that (i) has not expired; (ii) has not been disclaimed; (iii) has not been revoked, held invalid, or otherwise declared unenforceable or not allowable by a tribunal or patent authority of competent jurisdiction over such claim in such country from which no further appeal has or may be taken; and (iv) in the case of a pending application, was filed and is being prosecuted in good faith towards allowance for a period not to exceed [ * ] years.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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payment obligations hereunder, including, without limitation, the payment of any royalties described in Section 4.2 hereof. Licensee shall be permitted to require a Sublicensee to pay royalties directly to Licensor, but such requirement shall not alter Licensee’s payment obligations hereunder.
(a) Subject to the Preexisting Rights, at any time during the term of the Agreement, Licensee shall have the option from time to time to designate an Option Subfield within the Nonexclusive Licensed Field for inclusion within the Exclusive Licensed Field (a “Conversion Option”). Upon such designation by Licensee in writing to Licensor, Licensee shall pay to Licensor the Conversion Option Fee, as defined in Section 4.2.4, at which time such Option Subfield shall be considered subject to all terms of the Agreement that are applicable to the Exclusive Licensed Field and this Agreement shall be deemed automatically amended mutatis mutandis with no further action of either Party.
(b) If Licensee has converted pursuant to Section 2.1.4(a) its rights in the Nonexclusive Field relating to ID from nonexclusive to exclusive, then to the extent any additional rights licensed to the Preexisting Licensee in the field of ID are no longer subject to the Preexisting License (including the related option described herein) (“Available Rights”), such Available Rights shall be automatically deemed a part of the Exclusive Field under this Agreement. If Licensee has not converted its rights in the Nonexclusive Field relating to ID from nonexclusive to exclusive pursuant to the Conversion Option in Section 2.1.4(a), then such Available Rights shall be automatically deemed a part of the Nonexclusive Field.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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exercise by the Preexisting Licensee under the Preexisting Rights of any option to convert any rights therein from nonexclusive to exclusive, or the expiration, termination or lapse of any rights of the Preexisting Licensee under the Preexisting Rights. Such written notice shall be delivered to Licensee no later than [ * ] days after such material change.
3. DEVELOPMENT AND COMMERCIALIZATION OF LICENSED PRODUCTS.
3.1 Development and Commercialization.
3.1.1 Licensee shall use commercially reasonable efforts to develop and commercialize Licensed Product(s) in the U.S. and E.U., provided that such efforts are consistent with sound and reasonable business and scientific and medical practice and judgment and are considered in light of all relevant factors. All activities relating to Development and commercialization under this Agreement shall be undertaken at Licensee’s sole cost and expense, except as otherwise expressly provided in this Agreement.
3.1.2 From and after the Effective Date, Licensee shall have full control and authority over the development and commercialization of Licensed Products, including without limitation, (a) all pre-clinical development activities, including any pharmaceutical development work on formulations or process development relating to any Licensed Product, (b) all activities related to human clinical trials, including all clinical studies, (c) all activities relating to manufacture and supply of all Licensed Products (including all required process development and scale up work with respect thereto), (d) all marketing, promotion, sales, distribution, import and export activities relating to any Licensed Product, and (e) all activities relating to any regulatory filings, registrations, applications and Regulatory Approvals relating to any of the foregoing including any INDs or foreign equivalents, any manufacturing facility validation and/or licensure, any Drug Approval Applications and any other Regulatory Approvals. Licensee shall own all data, results and all other information arising from any such activities under this Agreement, including without limitation, all regulatory filings, registrations, applications and Regulatory Approvals relating to Licensed Products, including any INDs or foreign equivalents, any Drug Approval Applications and any other Regulatory Approvals, and all of the foregoing information, documentation and materials shall be considered Confidential Information and Technology solely owned and Controlled by Licensee.
4. FEES, ROYALTIES AND MILESTONES
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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4.2 Payment of Royalties; Royalty Rates; Minimum Royalties.
4.2.1 Royalty Payments. In further consideration of the grant of the licenses described in Article 2 hereof and its other rights hereunder, Licensee shall pay to Licensor on the terms set forth herein the following royalties:
in respect of each Licensed Products sold for use in the Nonexclusive Licensed Field, a royalty equal to [ * ] of Net Sales of such Licensed Product and
in respect of each Licensed Products sold for use in the Exclusive Licensed Field, a royalty equal to [ * ] of Net Sales of such Licensed Product.
Only one royalty shall be payable to Licensor hereunder for each sale of a Licensed Product.
4.2.2 Minimum Royalties.
Licensee agrees to pay to Licensor an annual minimum royalty of [ * ], creditable against any royalty due under the Agreement (even if such credit is taken in a calendar year, other than the one in which the payment is made), beginning at the first anniversary of the Agreement and continuing annually thereafter.
4.2.3 Third Party Royalty Offset. If Licensee, in its commercially reasonable discretion, obtains a license to any Third Party intellectual property rights related to Licensed Product, payments due to such Third Party licensor for such rights will be creditable at times determined by Licensee against the royalty owed to Licensor, provided that (i) Licensee shall keep Licensor reasonably informed of all related negotiations (after reaching a termsheet) with Third Parties and consult Licensor in connection therewith and (ii) royalties owed to Licensor hereunder shall not be reduced by more than [ * ] in the aggregate. For clarity, any information provided by Licensee to Licensor pursuant to this provision is the Confidential Information of Licensee and Licensee shall not attempt to contact any such Third Party absent the express written consent of Licensee.
4.2.4 Conversion Option Fee. For each Option Subfield for which Licensee exercises a Conversion Option, Licensee shall pay to Licensor a nonrefundable, non-creditable Conversion Option Fee in the sum of [ * ] within [ * ] days following exercise of such Conversion Option.
(i) | [ * ] upon [ * ]; |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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(ii) | [ * ] upon [ * ]; |
(iii) | [ * ] upon [ * ]; and |
(iv) | [ * ] upon [ * ]. |
The foregoing milestones shall be payable one time per Licensed Product (without regard to such Licensed Product’s indications for use or whether the Licensed Product is modified, re-formulated, re-launched, or modified). In addition, only one set of milestones shall be payable per Subfield.
4.4 Sublicensing Consideration.
4.4.1
(a) Subject to the other terms hereof, Licensee shall pay to Licensor a share of the cash value of compensation as and when received by Licensor to the extent attributable to the grant of a sublicense of the rights granted by Licensor to Licensee under this Agreement, including all sublicensing income, licensing fees, milestone payments, patent infringement damage awards, equity investments in Licensee or its Affiliate(s) to the extent such investments exceed [ * ] of Fair Market Value (as defined below), and any other sublicensing revenue other than Excluded Payments (in the aggregate, “Attributed Income”). Such Attributed Income shall not include the following (“Excluded Payments”): payments received from Sublicensee(s) for royalties on sales of Licensed Products; payments received for debt financing; payments for equity investments at or below [ * ] of Fair Market Value; payments or other consideration for research contracts or development, sales and/or marketing activities; reimbursement for patent costs; and milestones payments payable to Licensee under the sublicense agreement. Licensee will provide relevant information in its possession regarding exclusions from sublicense consideration to the extent such information is not the confidential information of a Third Party. All such information shall be treated as the Confidential Information of Licensee.
(b) In the event that equity in lieu of cash or other consideration is received by Licensee in return for granting a sublicense, Licensee shall either arrange for Licensor’s share of such equity to be issued directly to Licensor and in the name of “Karagen Pharmaceuticals”, if permitted and commercially reasonable, or Licensee shall pay in cash to Licensor the Fair Market Value (as defined below) of Licensor’s share of such equity. The term “Fair Market Value” shall mean (i) if the stock is publicly traded, the average closing price at which the stock in question is publicly traded at for [ * ] trading days prior to the execution of the sublicense agreement, or (ii) if the stock is not publicly traded, the value of such stock shall be (x) the price of the stock during the most recent round of financing, provided the round shall have been completed not more than [ * ] months prior, or (y) if there has not been a round in the
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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[ * ] months prior to the execution of the sublicense agreement, then price determined by a single independent appraisal of an appraiser chosen by Licensee and approved by Licensor, such approval not unreasonably withheld, conditioned or delayed.
4.4.2 Licensor’s share of Attributed Income shall be determined as follows, based on the stage of development of the most advanced Licensed Product candidate that is the subject of the sublicense:
(i) | [ * ] if [ * ]; |
(ii) | [ * ] if [ * ]; |
(iii) | [ * ] if [ * ]; and |
(iv) | [ * ]. |
4.4.3 In the event that Aduro exercises its Conversion Option, Licensor’s share of Attributed Income for the grant of a sublicense of such rights shall be determined as follows, based on the stage of development of the most advanced relevant Licensed Product candidate that is the subject of the sublicense:
(i) | [ * ] if [ * ]; |
(ii) | [ * ] if [ * ]; |
(iii) | [ * ] if [ * ]; and |
(iv) | [ * ]. |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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4.5.4 Payment of Fees and Milestones. Fees and Milestones shall be paid as set forth herein.
4.6 Records Retention; Review.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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5. TREATMENT OF CONFIDENTIAL INFORMATION
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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5.3 Publicity. Licensee may publicly disclose the existence or terms or any other matter of fact regarding this Agreement without the prior written consent of the Licensor. Either Party may make such a disclosure (a) to the extent required by law or by the requirements of any nationally recognized securities exchange, quotation system or over-the-counter market on which such Party has its securities listed or traded, or (b) to any investors, prospective investors, lenders and other potential financing sources who are obligated to keep such information confidential. In the event that such disclosure is required as aforesaid, the disclosing Party shall make reasonable efforts to provide the other Party with notice beforehand and to coordinate with the other Party with respect to the wording and timing of any such disclosure. The Parties, upon the execution of this Agreement, will mutually agree to a press release with respect to this transaction for publication. Once such press release or any other written statement is approved for disclosure by both Parties, either Party may make subsequent public disclosure of the contents of such statement without the further approval of the other Party.
6. PROVISIONS CONCERNING THE FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS
6.1 Patent Filing, Prosecution and Maintenance.
(a) Subject to the other terms of this Agreement, Licensor shall be responsible for preparing, filing, prosecuting, obtaining and maintaining, at its sole cost, expense and discretion, and using patent counsel reasonably acceptable to Licensee, all Licensed Patent Rights in the Territory. Licensor (i) will provide Licensee with a copy of any and all proposed patent applications within Licensed Patent Rights and relevant to the Exclusive Licensed Field and Nonexclusive Licensed Field for review and comment reasonably in advance of filing which shall under no circumstances be less than [ * ] days, and (ii) will keep Licensee fully and timely informed of the status of such filing, prosecution and maintenance, including, without limitation, (A) by providing Licensee with copies of all communications and key strategy received from or filed in patent office(s) with respect to such filing, and (B) by providing Licensee, a reasonable time prior to taking or failing to take any action that might affect the scope or validity of any such of any such filing (including the substantially narrowing, cancellation or abandonment of any claim(s) without retaining the right to pursue such subject matter in a separate application, or the failure to file or perfect the filing of any claim(s) in any country), with prior written notice of such proposed action or inaction so that Licensee has a reasonable opportunity to review and comment.
(b) If Licensor fails to undertake the filing(s) of any patent application or submission with respect to any invention under such Licensed Patent Rights, then not less than [ * ] days prior to the last date for making the applicable filing or submission to preserve rights under such patent application (the “Last Date”), Licensee may undertake such filing(s) at its own expense, the cost of which may be offset against amounts owed to Licensor (“Licensee Intervention”). In such case, Licensor will assign to Licensee all of its rights to such patent application and invention and any subsequently issued patent thereon in the country or countries in which Licensee undertakes such filing(s), each of which thereafter will be owned solely by
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Licensee, unless Licensor repays to Licensee within [ * ] days after the Last Date all of Licensee’s costs and expenses (including reasonable attorney fees, agent fees and filing fees) in preparing and making such filings (the “Licensor Option to Cure”). The Licensor Option to Cure may be exercised by Licensor only after the first two occurrences of a Licensee Intervention, after which Licensor shall no longer be permitted the Licensor Option to Cure.
(c) Should this Agreement be validly terminated for Licensee’s uncured material breach, then Licensed Patent Rights assigned to Licensee pursuant to this Section shall be re-conveyed to Licensor by Licensee.
6.2 Notice of Infringement. If, during the License Term, either Party learns of any actual, alleged or threatened infringement by a Third Party of any Licensed Patent Rights under this Agreement, such Party shall promptly notify the other Party and shall provide such other Party with available evidence of such infringement.
6.3 Infringement of Patent Rights.
(a) Licensor shall have the first right to enforce any Patent Rights among the Licensed Patent Rights and/or Improvements relating to Licensed Products in the Nonexclusive License Field against any infringement or alleged infringement at Licensee’s expense, such expense to be pro-rated according to the number of licensees, provided that if Licensor does not take an appropriate action within [ * ] days after notice, or if it fails to diligently prosecute such action(s), then Licensee may take or assume such actions in its own name (with the cooperation of Licensor) and Licensee will thereafter have the right to enforce such License Patent Rights and/or Improvements. Licensor shall cooperate fully therewith, including agreeing to be joined as a party to such action if necessary or helpful.
(b) Licensee shall have the first right to enforce any Patent Rights among the Licensed Patent Rights and/or Improvements relating to Licensed Products indicated for use in the Exclusive Licensed Field against any infringement or alleged infringement. Licensor shall fully cooperate in any such litigation at Licensee’s expense, including by agreeing to be joined as a party to such litigation if necessary or helpful.
(c) Any damages, monetary awards or other amounts recovered, whether by judgment or settlement, pursuant to any suit, proceeding or other legal action taken under this Section 6.3, shall applied as follows:
(i) | first, [ * ]; |
(ii) | second, [ * ]; and |
(iii) | third, any amounts remaining go to [ * ]. |
If a Party brings any such action or proceeding hereunder, the other Party agrees to be joined as party plaintiff if necessary to prosecute such action or proceeding, and to give the Party bringing such action or proceeding reasonable assistance and authority to file and
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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prosecute the suit; provided, however, that neither Party shall be required to transfer any right, title or interest in or to any property to the other Party or any Third Party to confer standing on a Party hereunder.
7. REPRESENTATIONS, WARRANTIES, AND CERTAIN COVENANTS
7.1 Licensor Representations. Licensor represents, warrants and covenants to Licensee as follows.
(a) The execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate Licensor corporate action.
(b) This Agreement is a legal and valid obligation binding upon Licensor and enforceable in accordance with its terms, and the execution, delivery and performance of this Agreement by the Parties does not conflict with any agreement, instrument or understanding to which Licensor is a party or by which it is bound.
(c) Licensor has the full right and legal capacity to grant the rights granted to Licensee hereunder without violating the rights of any Third Party.
(d) The Licensed Patent Rights have been properly filed, prosecuted, and maintained, and Licensor is the sole owner of the Licensed Patent Rights and Licensed Technology.
(e) Licensor is not aware of any Third Party patent, patent application or other intellectual property rights that would be infringed (i) by practicing any process or method or by making, using or selling any composition that is claimed or disclosed in, or that constitutes, Licensed Technology, or (ii) by making, using, offering for sale, selling or importing Licensed Products.
(f) Licensor is not aware of any infringement or misappropriation by a Third Party of the Licensed Technology.
(g) Licensor represents and warrants that, other than the Preexisting Rights, no other licenses have been granted to the Licensed Patent Rights, Licensed Technology or Improvements. In connection therewith and described herein and in Exhibit A, the Preexisting Licensee has a nonexclusive license to the Licensed Patent Rights only to use c-di-GMP only in the field of ID and a limited option to convert its rights for c-di-GMP on an ID on a field-by-field basis. Licensor covenants that it will not extend the term of the Preexisting License or expand or extend the option rights under the Preexisting Licensee. The Preexisting License was an arm’s length transaction and Licensor, its directors, officers, and employees and their family members have no interest in the Preexisting Licensee or its Affiliates.
(h) Except as set forth in this Section 7.1 and in Exhibit A hereto, the Preexisting Licensee has no other rights and the Preexisting License does not contain any other provisions that might adversely affect Licensee’s rights or increase Licensee’s obligations under this Agreement.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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(i) Exhibit A is true, correct and complete in all respects.
(j) All agreements effective on or after the Effective Date related to the License Patent Rights or Licensed Technology Rights, including without limitation any agreement with the Preexisting Licensee or its Affiliates or development partners, shall (i) only contain provisions that are subject to those set forth in this Agreement, (ii) will not include rights outside the field of ID and (iii) will permit Licensee to review copies of the agreements redacted to remove key information identifying the party and financial terms (to the extent not already publicly available).
(k) Licensor shall keep Licensee fully informed of any infringement of the License Patent Rights or appropriation of the License Technology by the Preexisting Licensee in the Exclusive Field, Nonexclusive Field and outside of ID. Licensor agrees to fully cooperate in the enforcement of all of the terms of this Agreement and the terms of the Preexisting License and any successor agreement, and permit Aduro to lead such enforcement and offset against payments owed to Licensor hereunder the reasonable costs thereof.
7.2 Licensee Representations. Licensee represents and warrants to Licensor as follows.
(a) The execution and delivery of this Agreement and the performance of the transactions contemplated hereby have been duly authorized by all appropriate Licensee corporate action.
(b) This Agreement is a legal and valid obligation binding upon Licensee and enforceable in accordance with its terms, and the execution, delivery and performance of this Agreement by the Parties does not conflict with any agreement, instrument or understanding to which Licensee is a party of or by which it is bound.
(c) Licensee acknowledges that Licensor has represented to Licensee that Licensor has entered into a Preexisting License and, while Licensee’s exclusive rights hereunder are unaffected thereby, certain of Licensee’s nonexclusive rights and related options are subject to those Preexisting Rights to the extent demonstrated herein. For clarity, Licensee has not been permitted to see or review any version of the Preexisting License and Licensee is relying entirely on Licensor’s account of its provisions.
Except as expressly set forth in this Agreement, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR OF NON-INFRINGEMENT OF ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS OF THIRD PARTIES, OR ANY OTHER EXPRESS OR IMPLIED WARRANTIES.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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8.3 Certain Limitations of Liability.
8.3.1 IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR INDIRECT DAMAGES OR CONSEQUENTIAL DAMAGES, INCLUDING WITHOUT LIMITATION, LOST PROFITS, OPPORTUNITIES OR REVENUES, PROVIDED NO LIMITATION HEREIN SHALL LIMIT ANY AMOUNT PAYABLE BY A PARTY UNDER SECTION 8.1.1 OR 8.1.2 HEREOF, OR LOSSES ARISING FROM GROSS NEGLIGENCE, WILLFUL MISCONDUCT, FRAUD, OR A BREACH OF ARTICLE 5 OF THIS AGREEMENT.
8.3.2 NOTWITHSTANDING ANYTHING TO THE CONTRARY, THE PARTIES ACKNOWLEDGE THAT ANY LOST PROFITS OF LICENSEE OR ITS AFFILIATES OR SUBLICENSEES ARISING FROM A BREACH BY LICENSOR OF SECTION 7.1 OR EXHIBIT A SHALL BE DEEMED DIRECT DAMAGES FOR THE PURPOSE OF CALCULATING LICENSEE LOSSES.
9.2 Termination Rights for Breach.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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(a) Upon any termination of this Agreement by Licensee under Section 9.2.1 for Licensor’s material breach, or under Section 9.3 where Licensor has filed for protection under bankruptcy laws or has an involuntary bankruptcy petition filed against it that is not discharged within sixty (60) days of the filing, as of the effective date of such termination, Licensee thereafter automatically shall have a fully sublicensable and transferable, fully paid up (subject to the remainder of this Section 9.4), nonexclusive or exclusive (as the case may be) license in the Territory under the Licensed Patent Rights and Licensed Technology, to develop, have developed, make, have made, use, have used, sell, have sold, offer for sale, import and have imported any and all Licensed Products and to practice the Licensed Technology in the Territory, provided that Licensee shall pay, for the remainder of any royalty term under Section 4.4 above, in lieu of any payments including milestones or royalties it would otherwise owe to Licensor under this Agreement, a royalty equal to sixty-six percent (66%) of the royalty rate that would otherwise apply with respect to the Licensed Product under Sections 4.2.1, 4.2.2, 4.2.3 and 4.2.4 of this Agreement.
(b) In the event of a transfer under Section 9.2.2, the Parties shall return to one another their respective Confidential Information, provided Licensee may retain one copy of the same for legal archives and one copy for any countries in which it has a fully paid license.
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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The Parties recognize that a bona fide dispute relating to either Party’s rights or obligations hereunder, may from time to time arise during the Term. In the event of the occurrence of such a dispute, either Party may, by written notice to the other Party, have such dispute referred to their respective senior officials designated below or their successors, for attempted resolution by good faith negotiations within [ * ] days after such notice is received. Said designated senior officials are as follows:
For Licensee: Chief Executive Officer
For Licensor: President
In the event the designated senior officials are not able to resolve such dispute within the [ * ] day period, either Party may seek any remedies available to it; provided that the foregoing shall not be construed to prohibit a Party from immediately seeking protection or relief it deems reasonable in light of the circumstances.
If to Licensor: | Xxxx Xxxxx-Xxxxxxxx President Karagen Pharmaceuticals, Inc. 0 Xxxx Xxxx Xxxxxxxxx, XX 00000 | |
With a copy to: | Royal X. Xxxxx Ober, Kaler, Xxxxxx & Xxxxxxx 000 Xxxxx Xxxxxx Xxxxxxxxx, XX 00000 |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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If to Licensee: | Xxxxxxx X. Xxxxxx Chairman and CEO Aduro BioTech, Inc. 000 Xxxxxxxx Xxx, Xxxxx 0X Xxxxxxxx, XX 00000 FAX: [ * ] [ * ] | |
With a copy to: | Xxxxxx Xxxxxxxx Associate Director, Strategic Development Aduro BioTech, Inc. 000 Xxxxxxxx Xxx, Xxxxx 0X Xxxxxxxx, XX 00000 FAX: [ * ] [ * ] |
All notices, requests and other communications hereunder shall be deemed to have been given either (i) if by hand, at the time of the delivery thereof to the receiving party at the address of such party set forth above, (ii) if made by telecopy or facsimile transmission, at the time that receipt thereof has been acknowledged by the recipient, (iii) if sent by private courier, on the day such notice is delivered to the recipient, or (iv) if sent by registered or certified mail, on the fifth (5th) business day following the day such mailing is made.
11.3 Governing Law. This Agreement will be construed, interpreted and applied in accordance with the laws of the California (excluding its body of law controlling conflicts of law).
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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11.13 Section 365(n). All licenses granted under this Agreement are deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined in Section 101 of such Code. The Parties agree that Licensee may fully
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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exercise all of its rights and elections under the U.S. Bankruptcy Code, regardless of whether either Party files for bankruptcy in the United States or other jurisdiction. The Parties further agree that, in the event Licensee elects to retain its rights as a licensee under such Code, Licensee shall be entitled to complete access to any technology licensed to it hereunder and all embodiments of such technology. Such embodiments of the technology shall be delivered to the Licensee not later than:
(a) the commencement of bankruptcy proceedings against the Licensor, upon written request, unless the Licensor elects to perform its obligations under the Agreement, or
(b) if not delivered under Section 11.14 above, upon the rejection of this Agreement by or on behalf of Licensee, upon written request.
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[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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KARAGEN PHARMACEUTICALS, INC. | ADURO BIOTECH, INC. | |||||||
By: | /s/ Xxxx Xxxxx-Xxxxxxxx | By: | /s/ Xxxxxxx X. Xxxxxx | |||||
Title: | President | Title: | Chairman & CEO |
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Exhibit A
Preexisting Rights Description
[ * ]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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Exhibit B
Licensed Patent Rights
[ * ]
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
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