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RESEARCH AND DEVELOPMENT COLLABORATION AND LICENSE AGREEMENT

Collaboration Agreement

RESEARCH AND DEVELOPMENT COLLABORATION AND LICENSE AGREEMENT | Document Parties: DYNAVAX TECHNOLOGIES CORPORATION | Edinburgh Pharmaceutical Industries Limited | Glaxo Group Limited You are currently viewing:
This Collaboration Agreement involves

DYNAVAX TECHNOLOGIES CORPORATION | Edinburgh Pharmaceutical Industries Limited | Glaxo Group Limited

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Title: RESEARCH AND DEVELOPMENT COLLABORATION AND LICENSE AGREEMENT
Governing Law: Delaware     Date: 3/6/2009
Industry: Biotechnology and Drugs     Law Firm: Cooley Godward     Sector: Healthcare

RESEARCH AND DEVELOPMENT COLLABORATION AND LICENSE AGREEMENT, Parties: dynavax technologies corporation , edinburgh pharmaceutical industries limited , glaxo group limited
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Exhibit 10.39

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

R ESEARCH AND D EVELOPMENT C OLLABORATION AND L ICENSE A GREEMENT

B ETWEEN

G LAXO G ROUP L IMITED

AND

D YNAVAX T ECHNOLOGIES C ORPORATION


RESEARCH AND DEVELOPMENT COLLABORATION

AND LICENSE AGREEMENT

This RESEARCH AND DEVELOPMENT COLLABORATION AND LICENSE AGREEMENT (the “ Agreement ”) is entered into and made effective as of the 15th day of December, 2008 (the “ Effective Date ”) by and between Dynavax Technologies Corporation, a Delaware corporation having its principal place of business at 2929 Seventh Street, Suite 100, Berkeley, CA 94710 (“ Dynavax ”), and Glaxo Group Limited, a company existing under the laws of England and Wales, having its registered office at Glaxo Wellcome House, Berkeley Avenue, Greenford, Middlesex, UB6 0NN, England (“ GSK ”). Dynavax and GSK are each referred to herein by name or as a “ Party ” or, collectively, as “ Parties.

RECITALS

W HEREAS , Dynavax possesses proprietary technology and know-how related to the discovery, identification, synthesis and development of oligonucleotides as drug candidates;

W HEREAS , GSK possesses expertise in the research, development, manufacturing and commercialization of human pharmaceuticals, and GSK is interested in developing such oligonucleotides as drug products;

W HEREAS , GSK desires to engage in a collaborative effort with Dynavax pursuant to which Dynavax will carry out up to three (3) different research and development programs to discover and develop oligonucleotides as inhibitors of certain toll-like receptors (or combinations thereof), and pursuant to which GSK will have certain options, exercisable at GSK’s sole discretion, to further develop and commercialize such oligonucleotides for any and all uses in the Territory (as defined below), all on the terms and conditions set forth herein.

N OW , THEREFORE , in consideration of the premises and mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:

ARTICLE 1

DEFINITIONS

As used in this Agreement, the following terms will have the meanings set forth in this Article 1 unless context dictates otherwise:

1.1 “Acceptance” means with respect to an NDA or MAA filed for a Product, (a) in the United States, the receipt by GSK or its Affiliate or Sublicensee of written notice from the FDA in accordance with 21 CFR 314.101(a)(2) that such NDA is officially “filed”, (b) in the European Union, receipt by GSK or its Affiliate or Sublicensee of written notice of acceptance by the EMEA of such MAA for filing under the centralized European procedure in accordance with any feedback received from European Regulatory Authorities; provided, that if the

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.


centralized filing procedure is not used, then Acceptance shall be determined upon the acceptance of such MAA by the applicable Regulatory Authority in the third Major Country in the EU, and (c) in Japan, receipt by GSK or its Affiliate or Sublicensee of written notice of acceptance of filing of such MAA from the MHLW.

1.2 “Affiliate” means any Person, whether de jure or de facto , which, directly or indirectly through one (1) or more intermediaries, controls, is controlled by or is under common control with a Party to this Agreement, regardless of whether such Affiliate is or becomes an Affiliate on or after the Effective Date. A Person shall be deemed to “control” another Person if it (a) owns, directly or indirectly, beneficially or legally, at least fifty percent (50%) of the outstanding voting securities or capital stock (or such lesser percentage which is the maximum allowed to be owned by a Person in a particular jurisdiction) of such other Person, or has other comparable ownership interest with respect to any Person other than a corporation; or (b) has the power, whether pursuant to contract, ownership of securities or otherwise, to direct the management and policies of the Person.

1.3 “Alliance Manager” has the meaning assigned to such term in Section 3.2.

1.4 “Annual Net Sales” means total Net Sales in the Territory in a particular Calendar Year.

1.5 “Arbitration Request” has the meaning assigned to such term in Section 13.2.

1.6 [ * ] means that certain [ * ] , as amended from time to time.

1.7 “Back-up Compound” means, with respect to a lead Compound in a Dynavax Program, a Compound in such Dynavax Program that (i) may or may not be a [ * ] to such lead Compound, (ii) has been or is expected to be advanced to the [ * ] stage by Dynavax, (iii) is expected to reasonably address [ * ] associated with such lead Compound, and (iv) is not a [ * ] .

1.8 “Breaching Party” has the meaning assigned to such term in Section 12.2.1.

1.9 “Business Day” means a day on which banking institutions in New York, New York, United States, and London, England are open for business, excluding any Saturday or Sunday.

1.10 “Calendar Day” means any day, including a Saturday, Sunday, Business Day or public or company holiday.

1.11 “Calendar Quarter” means a period of three (3) consecutive months ending on the last day of March, June, September, or December, respectively.

1.12 “Calendar Year” means a period of twelve (12) consecutive months beginning on January 1 and ending on December 31.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.13 cGMP ” means all applicable standards relating to manufacturing practicves for fine chemicals, intermediates, bulk products or Products, including (i) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 CFR Parts 210 and 211 and The Rules Governing Medicinal Products in the European Community, Volume IV, Good Manufacturing Practice for Medicinal Products, as each may be amended from time to time or (ii) standards promulgated by any governmental body having jurisdiction over the manufacture of a Compound, in the form of laws or regulations.

1.14 “Chairperson” has the meaning assigned to such term in Section 3.1.1.

1.15 “Change of Control Event” has the meaning assigned to such term in Section 13.4.

1.16 “Claims” has the meaning assigned to such term in Section 11.1.

1.17 “Clinical Trial” means a Phase 1 Clinical Trial, Phase 2 Clinical Trial, Phase 3 Clinical Trial, [ * ] or Proof of Concept Study.

1.18 “Co-Development Costs” means, with respect to a GSK Product, the sum of the following costs to the extent incurred after the exercise by GSK of an Option with respect to the GSK Development Program containing such GSK Product:

1.18.1 All direct internal and external Research and Development costs incurred by or on behalf of GSK or its Affiliates or Sublicensees or Dynavax and/or their respective Affiliates during such period in the conduct of the GSK Development Program (including but not limited to both Clinical Trials and any non-clinical activities or studies) that are required by a Regulatory Authority to support and obtain Regulatory Approval for such GSK Product in the U.S. (collectively, the “Co-Development Studies” ), and for product material, comparator drug and placebo used in the Co-Development Studies.

1.18.2 Allocable overhead as included [ * ] , for [ * ] costs described in Section 1.18.1, to the extent [ * ] described in Section 1.18.1, where allocable overhead shall mean costs incurred by GSK or its Affiliates or Sublicensees or Dynavax or its Affiliates that are attributable to the costs of [ * ] or such other generally accepted methods, in all cases as applied by the Party in accordance with its accounting standards on a consistent basis. Without limitation, allocable overhead shall not include the costs of [ * ] , including, by way of example, [ * ] .

Such costs as described in Section 1.18.1 and 1.18.2 shall be determined in accordance with applicable Generally Accepted Accounting Principles (GAAP) and in accordance with the Party’s accounting standards applied on a consistent basis.

1.19 “Co-Development Option” has the meaning assigned to such term in Section 5.5.1(a).

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.20 “Collaboration IP” means the Collaboration Know-How and the Collaboration Patents.

1.21 “Collaboration Know-How” means any Information pertaining to a Compound that is discovered, developed, invented or created solely by a Party or jointly by both Parties, or their respective agents, contractors, or Affiliates, during the Research Term and pursuant to a Dynavax Program, but prior to the earlier of GSK’s exercise of the Option or expiration of the Option with respect to such Dynavax Program.

1.22 “Collaboration Patent” means any Patent that claims or covers Collaboration Know-How that is not specifically disclosed, included, claimed or covered in the Dynavax Compound IP or the GSK Development IP.

1.23 Commercially Reasonable Efforts ” means the following: (a) with respect to Dynavax, such efforts that are consistent with the efforts and resources normally used by [ * ] in the exercise of its reasonable business discretion relating to the research, development and commercial progression of a potential pharmaceutical product owned by it or to which it has exclusive rights, with similar product characteristics as the relevant Compound or Product, which is of similar market potential at a similar stage in its development or product life as the relevant Compound or Product, taking into account issues of patent coverage, safety and efficacy, product profile, competitiveness of the marketplace, proprietary position, [ * ] , and profitability (including pricing and reimbursement status achieved or likely to be achieved); and (b) with respect to GSK, such efforts that are consistent with the efforts and resources normally used by [ * ] in the exercise of its reasonable business discretion relating to the development and commercialization of a prescription pharmaceutical product or over-the-counter product as appropriate owned by it or to which it has exclusive rights, with similar product characteristics as the relevant Compound or Product, which is of similar market potential at a similar stage in its development or product life as the relevant Compound or Product, taking into account issues of patent coverage, safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position, [ * ] and profitability (including pricing and reimbursement status achieved or likely to be achieved).

1.24 “Competitive Infringement” has the meaning assigned to such term in Section 8.5.1.

1.25 Compound ” means each compound comprising an oligonucleotide-based immunoregulatory sequence (“IRS”) that inhibits ( [ * ] unless otherwise mutually agreed by the JSC without escalation pursuant to Section 3.1.4) in a [ * ] (such [ * ] to be mutually agreed by the Parties through the JSC) for [ * ] or [ * ] , as applicable for that Program, and all derivatives and improvements of such compound, (a) that are existing as of the Effective Date or (b) that are Researched and/or Developed by Dynavax under a Dynavax Program or (c) as identified, further modified, optimized or otherwise Researched or Developed by GSK under a GSK Development Program. In particular, for the TLR 7/9 directed compounds, the oligonucleotide-based IRS must have [ * ] unless otherwise mutually agreed by the JSC without escalation pursuant to

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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Section 3.1.4. For those Programs involving [ * ] , the JSC may establish criteria by mutual agreement for [ * ] of a Compound with respect to [ * ] TLR in such Program. For clarity, nothing in this Section 1.25 or elsewhere in this Agreement shall require Dynavax to measure the [ * ] .

1.26 “Confidential Information” has the meaning assigned to such term in Section 9.1.

1.27 “Control,” “Controls,” “Controlled” or “Controlling” means, with respect to any intellectual property, possession of the ability to grant the licenses or sublicenses as provided herein without violating the terms of any agreement or other arrangement with any Third Party. A Party shall be deemed to Control Collaboration IP to the extent of its individual or joint interest therein, as applicable.

1.28 “Co-Promotion Agreement” has the meaning assigned to such term in Section 5.5.2(a).

1.29 “Develop” or “Development” means pre-clinical and clinical drug development activities relating to the development of Compounds, Products and/or processes and submission of information to a Regulatory Authority for the purpose of obtaining Regulatory Approval of a product, and activities to develop manufacturing capabilities for products. Development includes, but is not limited to, pre-clinical activities, pharmacology studies, toxicology studies, formulation, manufacturing process development and scale-up (including bulk compound production), manufacturing Compound or Product for Clinical Trials, quality assurance and quality control, technical support, pharmacokinetic studies, clinical studies and regulatory affairs activities.

1.30 “Development Plan” has the meaning assigned to such term in Section 2.2.

1.31 “Disclosing Party” has the meaning assigned to such term in Section 9.1.

1.32 “Dollars” or “$” means the legal tender of the U.S.

1.33 “Dynavax Compound IP” means Dynavax’s and its Affiliates’ interest in any: (a) Patents in the Territory that claim or cover the composition of matter or any method of making, use or sale of a Compound in the Field; and (b) Information that [ * ] for the making, use or sale of a Compound in the Field, in each case to the extent such Patents or Information are Controlled by Dynavax or its Affiliates (i) on the [ * ] , or (ii) thereafter [ * ] for any Patents which claim priority to any Patent filed during the Research Term. The Dynavax Compound IP excludes the Collaboration IP.

1.34 “Dynavax Compound Patents” means Patents in the Dynavax Compound IP.

1.35 “Dynavax Development Program” means a Dynavax Program for which GSK fails to exercise its Option before expiration or GSK declines its Option, a Dynavax Program that is terminated by the JSC or GSK, or a terminated GSK Development Program containing Compounds and Products that Dynavax elects to further Develop and commercialize.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.36 “Dynavax Product” means a Product Developed and commercialized by Dynavax under a Dynavax Development Program.

1.37 “Dynavax Program” means Dynavax’s Research and Development of Compounds through to either the [ * ] or completion of a [ * ] or Proof of Concept Study, as applicable. For clarity, there will be a maximum of [ * ] potential Dynavax Programs under this Agreement, which shall be the TLR 7/9 Program [ * ] , each of which is subject to the relevant diligence provisions and milestones as if separate programs hereunder) and up to two (2) additional Dynavax Programs as identified pursuant to Section 2.5.

1.38 “EMEA” means the European Medicines Evaluation Agency, and any successor entity thereto.

1.39 European Commission ” means the executive body of the European Union that has legal authority to grant marketing authorization approvals for pharmaceutical products in the European Union following scientific evaluation and recommendation from the EMEA or other applicable Regulatory Authorities.

1.40 “European Union” or “EU” means all countries that are officially recognized as member states of the European Union at any particular time during the Term.

1.41 “Exclusively Licensed IP” means, with respect to each Compound in a Dynavax Program for which GSK exercises the Option and receives rights upon exercise pursuant to Section 4.1, (a) Information in the Dynavax Compound IP and Dynavax’s and its Affiliates’ interest in the Collaboration Know-How, in each case that [ * ] for the making, use or sale of such Compound [ * ] , and (b) Dynavax Compound Patents and Dynavax’s and its Affiliates’ interest in the Collaboration Patents, in each case that claims or covers the [ * ] of such Compound.

1.42 “Executive Officers” has the meaning assigned to such term in Section 3.1.4.

1.43 “FDA” means the U.S. Food and Drug Administration, and any successor entity thereto.

1.44 “Field” means [ * ] the treatment, palliation, prevention and/or diagnosis of [ * ] .

1.45 “First Commercial Sale” means, with respect to each Product, the first sale for which revenue has been recognized by GSK or Dynavax or their respective Affiliate or Sublicensees for use or consumption by the general public of such Product in any country in the Territory after all required Regulatory Approvals (including, where applicable, pricing and reimbursement approval which is acceptable to GSK or Dynavax, as applicable depending upon which Party is going to be selling Product) have been granted, or such sale is otherwise

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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permitted, by the Regulatory Authority in such country, provided, that, the following shall not constitute a First Commercial Sale: (a) any sale to an Affiliate or Sublicensee unless the Affiliate or Sublicensee is the last entity in the distribution chain of the Product, (b) any use of such Product in Clinical Trials, preclinical activities or other Research or Development activities, or disposal or transfer of Products for a bona fide charitable purpose, (c) compassionate use, (d) so called “treatment IND sales” and “named patient sales,” and (e) use under the ATU system in France or other equivalent systems.

1.46 “[ * ]” means a Compound in Development in the [ * ] that (a) is or is reasonably expected to be [ * ] and (b) has [ * ] .

1.47 “[ * ]” means the Research and Development, within the [ * ] , of [ * ] to Compounds in the [ * ] .

1.48 “FTC” has the meaning assigned to such term in Section 4.1.5.

1.49 “FTE” means a full-time individual’s work time dedicated by Dynavax to the Dynavax Programs or by GSK to the GSK Development Programs, or in the case of less than a full-time dedicated individual, a full-time equivalent person year, based upon a total of [ * ] hours per year of Research, Development, manufacturing and commercialization work on or directly related to the Dynavax Programs or GSK Development Programs.

1.50 “Generic Product” has the meaning assigned to such term in Section 6.4.2(b).

1.51 GSK Development Compound ” means any Compound, including Back-up Compounds, within a Dynavax Program that has become a GSK Development Program upon GSK’s exercise of the Option.

1.52 “GSK Development IP” means any (a) Patents that claim or cover the composition of matter of a GSK Development Compound or GSK Product or the making, use, sale, [ * ] of a GSK Development Compound or GSK Product; and (b) any Information that [ * ] of a GSK Development Compound or GSK Product [ * ] , in each case to the extent such Patents or Information are Controlled by GSK or its Affiliates, but excluding any Collaboration IP and any Dynavax Compound IP or Exclusively Licensed IP.

1.53 “GSK Development Patent” has the meaning assigned to such term in Section 8.2.2.

1.54 “GSK Development Plan and Budget” has the meaning assigned to such term in Section 5.5.1(a).

1.55 GSK Development Program ” means a Dynavax Program for which GSK exercises its Option and that has not been terminated by GSK.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.56 “GSK Product” means a Product Developed and commercialized by GSK or its Affiliate or Sublicensee under a GSK Development Program.

1.57 “HSR” has the meaning assigned to such term in Section 4.1.5.

1.58 “IND” means an investigational new drug application filed with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations, including any amendments thereto. References herein to IND shall include, to the extent applicable, any comparable filing(s) outside the U.S. (such as a clinical trial application in the European Union).

1.59 “Indemnitee” has the meaning assigned to such term in Section 11.3.

1.60 “Information” means all tangible and intangible (a) information, techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, skill, experience, data, results (including pharmacological, toxicological and clinical test data and results, and Research or Development data, reports and batch records), analytical and quality control data, analytical methods (including applicable reference standards), full batch documentation, packaging records, release, stability, storage and shelf-life data, and manufacturing process information, results or descriptions, software and algorithms and (b) compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical material. As used in this Section 1.60, “ clinical test data ” shall be deemed to include all information related to the clinical or pre-clinical testing of a Compound or Product, including without limitation patient report forms, investigators’ reports, biostatistical, pharmaco-economic and other related analyses, regulatory filings and communications, and the like.

1.61 “Joint Steering Committee” or “JSC” has the meaning assigned to such term in Section 3.1.

1.62 “Know-How Royalty” has the meaning assigned to such term in Section 6.4.2(a).

1.63 “[ * ]” means the research and development of [ * ] , as of the Effective Date, in the TLR 7/9 Program and its Back-up Compounds.

1.64 “Losses” has the meaning assigned to such term in Section 11.1.

1.65 “Major EU Country” means any of the [ * ] .

1.66 “MAA” means a regulatory application filed with the EMEA or MHLW seeking Regulatory Approval of a Product, and all amendments and supplements thereto filed with the EMEA or MHLW.

1.67 “Materials” has the meaning assigned to such term in Section 2.10.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.68 “MHLW” means the Ministry of Health, Labour and Welfare of Japan, or the Pharmaceuticals and Medical Devices Agency (the “PMDA,” formerly known as IYAKUHIN SOGO KIKO), or any successor to either of them, as the case may be.

1.69 “NDA” means a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq. or its successor regulation) and all amendments and supplements thereto filed with the FDA.

1.70 “Net Sales” means, with respect to any Product, the gross invoiced sales price of such Product sold by GSK or Dynavax or their respective Affiliates or Sublicensees (the “ Selling Party ”) in finished product form, packaged and labeled for sale, under this Agreement in arm’s length sales to Third Parties, less deductions allowed to the Third Party customer by the Selling Party and actually incurred, allowed, paid, accrued or specifically allocated as reported by the Selling Party in its financial statements in accordance with the International Financial Reporting Standards (“IFRS”) for GSK (or any other Selling Party which accounts in accordance with IFRS) or US (as appropriate) Generally Accepted Accounting Principles for Dynavax (or any other Selling Party which accounts in accordance with US or UK (as appropriate) Generally Accepted Accounting Principles), applied on a consistent basis, for:

1.70.1 customary and reasonable trade, quantity, and cash discounts and wholesaler allowances; provided that, in the case of pharmacy incentive research programs, hospital performance incentive research program chargebacks, disease management research programs, similar research programs or discounts and wholesaler allowances on “bundles” of products, all discounts, wholesaler allowances and the like shall be [ * ] ;

1.70.2 customary and reasonable credits, rebates and chargebacks (including those to managed-care entities and government agencies), and allowances or credits to customers on account of rejection or returns (including, but not limited to, wholesaler and retailer returns) or on account of retroactive price reductions affecting such Product;

1.70.3 freight, postage and duties, and transportation charges relating to such Product, including handling and insurance thereto;

1.70.4 sales (such as VAT or its equivalent) and excise taxes, other consumption taxes, customs duties and compulsory payments to governmental authorities and any other governmental charges imposed upon the importation, use or sale of such Product to Third Parties (excluding any taxes paid on the income from such sales) to the extent the Selling Party is not otherwise entitled to a credit or a refund for such taxes, duties or payments made;

1.70.5 [ * ] ; and

1.70.6 other items actually deducted from gross sales in relation to changes in accounting guidelines as per IFRS and to the extent that such deductions are consistently applied across the relevant Party’s business.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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Sales between GSK and its Affiliates or Sublicensees, or Dynavax and its Affiliates or Sublicensees, as applicable, shall be excluded from the computation of Net Sales, and no payments will be payable on such sales except where such Affiliate or Sublicensee is the last entity in the distribution chain for the Product and is purchasing it for its own commercial use, in which case such sales shall be deemed to be at [ * ] . In addition, Product provided to patients for compassionate use will not be included in Net Sales. [ * ] .

For purposes of determining Royalties and sales milestones payable on Combination Products, Net Sales will be calculated as follows, in each calendar quarter:

In the event that Compound is sold as part of a Combination Product (as defined below), the Net Sales from the Combination Product will be determined by multiplying the Net Sales (as determined without reference to this paragraph) of the Combination Product by the fraction [ * ] , where [ * ] is the [ * ] of the Compound [ * ] when sold separately in finished form and [ * ] is the [ * ] of the other therapeutically active pharmaceutical compound(s) included in the Combination Product when sold separately in finished [ * ] , each during the applicable royalty period or, if sales of all compounds did not occur in such period, then [ * ] . In the event that such [ * ] cannot be determined for both the Compound and all other therapeutically active pharmaceutical compounds included in the Combination Product [ * ] , Net Sales for the purposes of determining royalty payments will be calculated as above, but the [ * ] in the above equation will be replaced by [ * ] of the compound(s) for which no such price exists. As used above, the term “Combination Product” shall mean any pharmaceutical product which contains a Compound together with at least one other therapeutically active pharmaceutical compound (whether or not co-formulated or co-packaged with the Compound in such Product) which is not a Compound. To be a Combination Product, products must be invoiced as one product. Notwithstanding the foregoing, drug delivery vehicles, adjuvants and excipients shall not be deemed to be active pharmaceutical compounds and their presence shall not be deemed to create a Combination Product. [ * ] .

To the extent the Net Sales is used herein with respect to Dynavax Products, Net Sales shall have the meaning set forth above, with all references to “GSK” replaced by “Dynavax.”

1.71 “Non-breaching Party” has the meaning assigned to such term in Section 12.2.1.

1.72 “[ * ]” has the meaning assigned to such term in Section 2.8.

1.73 “Option” has the meaning assigned to such term in Section 4.1.1.

1.74 “Option Deadline Extension Period” has the meaning assigned to such term in Section 4.1.5.

1.75 “Option Deadline Period” has the meaning assigned to such term in Section 4.1.5.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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1.76 “Option Period Start” has the meaning assigned to such term in Section 4.1.2.

1.77 “Party” or “Parties” has the meaning assigned to such term in the Preamble.

1.78 “Patent” means (a) all patents and patent applications in any country or supranational jurisdiction in the Territory, (b) any substitutions, divisions, continuations, continuations-in-part, provisional applications, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such patents or patent applications, and (c) foreign counterparts of any of the foregoing.

1.79 “Patent Costs” means the reasonable fees and expenses paid to outside legal counsel, and filing, maintenance and other out-of-pocket expenses paid to Third Parties, incurred in connection with the Prosecution and Maintenance of Patents.

1.80 “Patent Royalty” has the meaning assigned to such term in Section 6.4.1.

1.81 “Payee” has the meaning assigned to such term in Section 6.9.

1.82 “Payor” has the meaning assigned to such term in Section 6.9.

1.83 “Person” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.

1.84 “Phase 1 Clinical Trial” means a human clinical trial of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a), or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

1.85 “Phase 2 Clinical Trial” means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

1.86 “Phase 3 Clinical Trial” means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(c) and is intended to (a) establish that the product is safe and efficacious for its intended use, (b) define warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (c) support Regulatory Approval for such product.

1.87 “Phase I Ready Compound” means a Compound (including all Back-up Compounds if progressed to this stage) from a Dynavax Program that has met the applicable Phase I Ready Criteria, or is [ * ] such criteria.

 

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1.88 “Phase I Ready Criteria” means the clinical and/or non-clinical criteria (a) set forth in Exhibit C and as modified by the JSC [ * ] for the [ * ] TLR 7/9 Program and (b) established and as modified by the JSC pursuant to Section 2.6.2 for the other Dynavax Programs (including the [ * ] ), for advancement of a Pre-Candidate Selection Compound from a Dynavax Program into clinical Development. In general, Phase I Ready Criteria for a particular Compound will be reasonable and appropriate for [ * ] and generally may include: [ * ] .

1.89 “Phase I Ready Report” has the meaning assigned to such term in Section 2.7.2.

1.90 “Pre-Candidate Selection Criteria” means the criteria established by the JSC pursuant to Section 2.6.1 for [ * ] in the [ * ] TLR 7/9 Program and for Compounds in the [ * ] and the other Dynavax Programs, for advancement of a Compound from a Dynavax Program into IND-enabling studies. In general, the Pre-Candidate Selection Criteria for a particular Compound will be reasonable and appropriate for [ * ] and may include [ * ] .

1.91 “Pre-Candidate Selection Report” has the meaning assigned to such term in Section 2.7.1.

1.92 “Product” means any product that includes a Compound, whether or not as the sole active ingredient and in any dosage form or formulation.

1.93 “Product Marketing Plan” has the meaning assigned to such term in Section 5.5.2.

1.94 “Program” means a Dynavax Program, Dynavax Development Program, or GSK Development Program, as applicable.

1.95 “Proof of Concept” or “PoC” means the stage of Development at which a Phase I Ready Compound has successfully satisfied the Proof of Concept Criteria, as such criteria are determined by GSK.

1.96 “Proof of Concept Criteria” means the clinical and/or non-clinical criteria established [ * ] , pursuant to Section 2.6.5 and in accordance with the guidelines attached hereto as Exhibit D , to determine whether a Phase I Ready Compound demonstrates [ * ] . This shall include [ * ] and any other reasonable parameters. The Proof of Concept Criteria shall include, without limitation, [ * ] . The criteria may be different for each Dynavax Program.

1.97 “Proof of Concept Study” means a human clinical trial for a particular Phase I Ready Compound that meets the requirements of 21 C.F.R. Section 312.21(b) and is intended to explore [ * ] .

1.98 “Proof of Concept Study Design” or “PoC Study Design” means the design, content and endpoints for a Proof of Concept Study.

 

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1.99 “Proof of Concept Study Report” or “PoC Study Report” has the meaning assigned to such term in Section 2.7.4.

1.100 “[ * ]” or “[ * ]” means the stage of Development at which a Phase I Ready Compound has successfully satisfied the [ * ] Criteria, as such criteria are determined by [ * ] .

1.101 “[ * ] Criteria” means the criteria established by [ * ] pursuant to Section 2.6.3 and in accordance with the guidelines attached hereto as Exhibit E .

1.102 “[ * ]” or “[ * ] Study” means a study performed in humans in order to [ * ] of a particular Phase I Ready Compound in humans and to guide [ * ] .

1.103 “[ * ] Design” or “[ * ] Study Design” means the design, content and endpoints for a [ * ] .

1.104 “[ * ] Report” or “[ * ] Study Report” has the meaning assigned to such term in Section 2.7.3.

1.105 “Prosecuting Party” has the meaning assigned to such term in Section 8.2.3.

1.106 “Prosecution and Maintenance” or “Prosecute and Maintain” means, with regard to a Patent, the preparing, filing, prosecuting and maintenance of such Patent, as well as re-examinations, reissues, and requests for patent term adjustments and patent term extensions with respect to such Patent, together with the initiation or defense of interferences, the initiation or defense of oppositions and other similar proceedings with respect to the particular Patent, and any appeals therefrom. For clarification, “Prosecution and Maintenance” or “Prosecute and Maintain” shall not include any other enforcement actions taken with respect to a Patent.

1.107 “Receiving Party” has the meaning assigned to such term in Section 9.1.

1.108 “Regulatory Approval” means any and all approvals, licenses, registrations, or authorizations of any country, federal, supranational, state or local regulatory agency, department, bureau or other government entity that are necessary for the manufacture, use, storage, import, transport and/or sale of a particular Product in the applicable jurisdiction.

1.109 “Regulatory Authority” means the FDA in the U.S. or any health regulatory authority in another country in the Territory that is a counterpart to the FDA and holds responsibility for granting regulatory marketing approval for a Product in such country, including the European Commission and the MHLW, and any successor(s) thereto.

1.110 “Research” means the discovery, identification, research, characterization, modification, derivatization, optimization, and pre-clinical testing of pharmaceutical compounds.

1.111 “Research Term” has the meaning assigned to such term in Section 2.3.

 

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1.112 “Senior Executive Officers” has the meaning assigned to such term in Section 5.1.2.

1.113 “Subcommittee” has the meaning assigned to such term in Section 3.1.7.

1.114 “Sublicensee” means, with respect to a particular Product, a Third Party to whom GSK or Dynavax, as applicable, has granted a sublicense or license under any Dynavax Compound IP and/or Collaboration IP and/or Exclusively Licensed IP and/or GSK Development IP licensed to such Party pursuant to this Agreement, but excluding any Third Party acting solely as a distributor.

1.115 “[ * ]” means [ * ] .

1.116 “[ * ]” means that certain [ * ] , as amended from time to time, to the extent pertaining to [ * ] of TLRs.

1.117 “Term” has the meaning assigned to such term in Section 12.1.

1.118 “Territory” means the entire world.

1.119 “Third Party” means any entity other than Dynavax or GSK or an Affiliate of Dynavax or GSK.

1.120 “TLR” means any of the human toll-like receptors [ * ] , [ * ] , [ * ] and [ * ] .

1.121 “TLR 7/9 Program” means, collectively, the Dynavax Program directed toward the discovery, Research and Development of Compounds that inhibit both TLR 7 and TLR 9, [ * ] .

1.122 “United States” or “U.S.” means the United States of America and all of its territories and possessions.

1.123 “Valid Claim” means any claim within a pending ( [ * ] ), allowed or issued U.S. patent application or patent, or pending, accepted or issued patent application or patent in a jurisdiction outside the U.S., that has not expired, lapsed, been cancelled or abandoned, or been dedicated to the public, disclaimed, or held unenforceable, invalid, or cancelled by a court or administrative agency of competent jurisdiction in an order or decision from which no appeal has been or can be taken, including without limitation through opposition, reexamination, reissue or disclaimer.

 

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ARTICLE 2

RESEARCH AND DEVELOPMENT

2.1 Overview. Pursuant to this Agreement and as further provided in this Article 2, Dynavax will undertake the TLR 7/9 Program and, if identified and agreed pursuant to Section 2.5, one (1) or two (2) additional Dynavax Programs under the supervision of the JSC during the Research Term. The objective of the Dynavax Programs is the identification, optimization, Research and Development of Compounds, which Compounds GSK shall have Options to exclusively license on a worldwide basis, as provided in Article 4.

2.2 Development Plans. Each Dynavax Program will be carried out by Dynavax pursuant to a development plan (each, a “Development Plan” ) that will outline anticipated Research and Development activities to be conducted by Dynavax and [ * ] . Any estimates regarding [ * ] shall be intended as a general guide only, and Dynavax shall continue to progress each Dynavax Program with Commercially Reasonable Efforts, even if Commercially Reasonable Efforts would require a [ * ] set forth in the Development Plan. The initial Development Plan for the [ * ] TLR 7/9 Program has been agreed to by the Parties and is attached hereto as Exhibit A . Development Plans for the other Dynavax Programs will be prepared in accordance with Section 2.5. The Development Plan for the [ * ] will be prepared within [ * ] after the Effective Date, unless otherwise agreed by the JSC. From time to time during the Research Term [ * ] , Dynavax shall update each Development Plan (or applicable portion thereof) and shall submit such updated Development Plan to the JSC for review and comment. Dynavax shall consider all such comments in good faith before preparing an updated Development Plan, however each such Development Plan will be designed with the objective of enabling a determination upon completion of the Development Plan as to whether all of the criteria (either Pre-Candidate Selection Criteria, Phase I Ready Criteria, [ * ] Criteria or PoC Criteria) have been met. Each updated Development Plan shall replace the Development Plan previously in effect. Each Development Plan will be reviewed as necessary at each meeting of the JSC, and at any other time upon the request of either Party, and the JSC may suggest modifications, as appropriate, to reflect material scientific or commercial developments. In the event of any inconsistency between any Development Plan and this Agreement, the terms of this Agreement shall prevail and any such inconsistent portion of a Development Plan is hereby expressly rejected.

2.3 Research Term. The Research term shall commence on the Effective Date and shall expire [ * ] thereafter (the “ Initial Research Term ”), subject to extension (a) for up to [ * ] of the Parties, or (b)  [ * ] no later than [ * ] prior to expiration of the Initial Research Term, if [ * ] , as applicable, before the expiration of the Initial Research Term (as may be extended, the “ Research Term ”), and in such case, the Research Term shall be extended [ * ] .

2.4 Dynavax Programs.

2.4.1 Dynavax Responsibility. Prior to GSK’s exercise of an Option with respect to a Dynavax Program, Dynavax shall have primary responsibility for the Research and Development of each Compound (including, but not limited to, clinical trials and submissions to regulatory agencies) under such Dynavax Program in accordance with the applicable Development Plan. Subject to Sections 2.6.4 and 2.6.6, Dynavax shall be solely responsible for

 

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all internal and external expenses in connection with the Dynavax Programs. Subject to Section 5.2, Dynavax’s obligation to conduct each Dynavax Program shall terminate at the earlier of (a) GSK’s exercise of the Option with respect to such Dynavax Program, (b) expiration of the Research Term, as may be extended pursuant to Section 2.3, or (c)  [ * ] decision to terminate such Dynavax Program.

2.4.2 Diligence. The objective of each Dynavax Program is to discover and Develop [ * ] and, if applicable under [ * ] , Compounds satisfying the Proof of Concept Criteria or [ * ] Criteria, as applicable. During the Research Term, Dynavax shall use Commercially Reasonable Efforts to conduct each Dynavax Program and related Research and Development activities for such Dynavax Program in accordance with the applicable Development Plan. In particular and without limiting the generality of the foregoing, and subject to Sections 2.6.4 and 2.6.6, for each Dynavax Program, Dynavax shall use Commercially Reasonable Efforts to conduct Research and Development activities to identify [ * ] that satisfy the [ * ] for each Dynavax Program and, if determined pursuant to [ * ] , progress [ * ] through to either (i) completion of a [ * ] Study in an effort to achieve the [ * ] Criteria, or (ii) completion of a Proof of Concept Study in an effort to achieve the Proof of Concept Criteria, as determined pursuant to Section 2.6.5.

2.4.3 TLR 7/9 Program . The TLR 7/9 Program shall include efforts to discover, Research and Develop Compounds for [ * ] dual inhibitors of TLR 7 and TLR 9.

2.4.4 GSK Research Activities . GSK shall, upon Dynavax’s request, consult with Dynavax regarding the Research and Development of Compounds under each Dynavax Program. On a Dynavax Program-by-Dynavax Program basis, the Parties shall discuss and consider in good faith [ * ] , prior to GSK’s exercise of an Option with respect to such Dynavax Program in order to [ * ] . Dynavax shall [ * ] .

2.5 Identification of Additional Programs. [ * ] may propose to the JSC up to two (2) additional Dynavax Programs to be conducted by Dynavax during the [ * ] . Upon GSK’s request during the [ * ] of the [ * ] , GSK and Dynavax will identify and agree upon, through the JSC, such additional two (2) Dynavax Programs to include under this Agreement, which during the [ * ] of the [ * ] , would involve Research and Development of inhibitors of [ * ] , and during the [ * ] of the [ * ] , would involve Research and Development of inhibitors of [ * ] . If the JSC cannot reach consensus on the selection of one or both of such additional Dynavax Programs, then [ * ] in accordance with Section 3.1.4(c). Promptly after each such Dynavax Program is selected, Dynavax shall prepare a Development Plan for such Program for submission to the JSC for review and comment. Dynavax shall consider all such comments in good faith before finalizing such Development Plan, after which Dynavax shall promptly commence and conduct such Program with its Commercially Reasonable Efforts.

2.6 Compound Criteria; [ * ] and Proof of Concept Study Designs.

2.6.1 Pre-Candidate Selection Criteria . The JSC shall establish the Pre-Candidate Selection Criteria for each Dynavax Program within (a)  [ * ] of the Effective Date for

 

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Back-up Compounds in the [ * ] TLR 7/9 Program and for the [ * ] , or (b)  [ * ] of the identification of each other Dynavax Program under Section 2.5. Such Pre-Candidate Selection Criteria shall be consistent with the generic criteria attached in Exhibit B , modified as necessary by mutual agreement of the JSC [ * ] .

2.6.2 Phase I Ready Criteria . As of the Effective Date, the Parties have agreed upon the Phase I Ready Criteria for the [ * ] TLR 7/9 Program, which criteria may be modified by mutual agreement of the JSC [ * ] . The JSC shall establish the Phase I Ready Criteria for the [ * ] within [ * ] TLR 7/9 Program. Within [ * ] after the identification of a Dynavax Program under Section 2.5, the JSC shall establish Phase I Ready Criteria for such Dynavax Program, which shall be substantially similar to the example of Phase I Ready Criteria set forth in Exhibit C .

2.6.3 [ * ] Criteria . Prior to the determination by the JSC of a Phase 1 Ready Compound for a given Dynavax Program, GSK or Dynavax may propose that Dynavax [ * ] for such Program, by submitting to the JSC proposed [ * ] Criteria and [ * ] Study Design that are reasonably consistent with the guidelines attached hereto as Exhibit E . The JSC shall consider such proposal and determine, [ * ] , whether such Dynavax Program will include a [ * ] . Promptly following a decision by the JSC to conduct a [ * ] Study, but in no event later than [ * ] over the [ * ] Criteria.

2.6.4 [ * ] Design. The JSC shall be responsible for establishing the [ * ] Design for each Dynavax Program for which a [ * ] Study will be conducted. Notwithstanding [ * ] with respect to the [ * ] Study Design, as set forth in Section 3.1.4(c), in no event shall Dynavax be obligated to [ * ] for any single [ * ] Study and all Development activities required specifically for such [ * ] Study. In the event that the [ * ] Study conducted in accordance with the applicable [ * ] Study Design and Development Plan, and all Development activities required specifically for such [ * ] Study, [ * ] , then [ * ] , except to the extent due to [ * ] . In the event that Dynavax [ * ] for a PoC Study and all Development activities required specifically for such PoC Study, [ * ] , as such PoC Study and all Development activities required specifically for such [ * ] at the time of a JSC decision [ * ] for any single [ * ] Study and all Development activities required specifically for such [ * ] Study, [ * ] for such [ * ] Study and all Development activities required specifically for such [ * ] Study against [ * ] for such Dynavax Program after the completion of such [ * ] Study. In the event that Dynavax [ * ] of [ * ] for any single [ * ] Study and all Development activities required specifically for such [ * ] Study, [ * ] Calendar Days after [ * ] provided by Dynavax setting forth [ * ] for such [ * ] Study in the preceding Calendar Quarter. [ * ] of such [ * ] against [ * ] of each milestone set forth in Sections [ * ] , up to a [ * ] of [ * ] . In any event, Dynavax shall be obligated to complete any [ * ] Study [ * ] pursuant to this Section 2.6.4.

2.6.5 Proof of Concept Criteria. Prior to the initiation of the first applicable [ * ] for a Program, [ * ] shall establish the provisional clinical trial design, including planned [ * ] , for the Proof of Concept Study, and shall [ * ] , collectively, as the Proof of Concept Criteria, prior to initiation of the PoC Study. All such Proof of Concept Criteria shall be established reasonably in accordance with the guidelines and examples attached hereto as Exhibit D .

 

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2.6.6 PoC Study Design . The JSC shall be responsible for [ * ] for each Dynavax Program. Notwithstanding [ * ] with respect to the PoC Study Design, as set forth in Section 3.1.4(c), in no event shall Dynavax be obligated to [ * ] of [ * ] for any single Proof of Concept Study and all Development activities required specifically for such Proof of Concept Study. In the event that the [ * ] for any Proof of Concept Study conducted in accordance with the applicable PoC Study Design and Development Plan, and all Development activities required specifically for such Proof of Concept Study, [ * ] , then [ * ] , except to the extent due to [ * ] within [ * ] after [ * ] provided by Dynavax setting forth the [ * ] for such Proof of Concept Study in the preceding Calendar Quarter. [ * ] of such [ * ] against [ * ] of each milestone set forth in Sections 6.2.1 and 6.2.2, up to a [ * ] of [ * ] . In any event, Dynavax shall be obligated to complete any PoC Study funded by GSK pursuant to this Section 2.6.6.

2.7 Evaluation of Pre-Candidate Selection Criteria, Phase I Ready Criteria, [ * ] Criteria and Proof of Concept Criteria.

2.7.1 Pre-Candidate Selection Criteria . In the event that a Compound achieves [ * ] of the Pre-Candidate Selection Criteria after Dynavax has completed the activities required to make such an assessment, it being understood by the Parties that drug discovery is an iterative problem-solving process and that multiple Compounds may be expected to be progressed in order to identify a Compound that merits advancement into IND-enabling studies, Dynavax shall promptly notify GSK in writing of such event and shall provide to the JSC a completed data package containing the complete set of the analyses, results and raw data from the Dynavax Program for such Compound (the “ Pre-Candidate Selection Report ”). Unless otherwise agreed to by the Parties, the JSC will schedule an ad hoc meeting not more than [ * ] after receipt by GSK’s JSC representatives of such complete Pre-Candidate Selection Report to review such Pre-Candidate Selection Report and to confirm whether or not such Compound meets [ * ] of the Pre-Candidate Selection Criteria. In the event that the JSC agrees that all or substantially all of the Pre-Candidate Selection Criteria have been met, [ * ] , and Dynavax shall use its Commercially Reasonable Efforts to continue to progress the Dynavax Program through to completion of the PoC Study or [ * ] Study, as applicable, subject to Section 2.7.2 below. If the JSC fails to agree that [ * ] of the Pre-Candidate Selection Criteria have been met, then the matter shall be resolved by [ * ] determines that all or substantially all of the Pre-Candidate Selection Criteria have been met, then the [ * ] , and Dynavax shall use its Commercially Reasonable Efforts to continue to progress the Dynavax Program through to completion of the PoC Study or [ * ] Study, as applicable under the relevant provisions of Articles 2 and 3. [ * ] of the Pre-Candidate Selection Criteria have been met, then Dynavax shall complete any additional studies as are [ * ] Pre-Candidate Selection Criteria and progress such Compound through completion of the PoC study or [ * ] Study, as applicable under the relevant provisions of Articles 2 and 3. If the achievement of such criteria is [ * ] , Dynavax shall instead progress a Backup Compound in place of the Compound that failed to meet the criteria, and Dynavax shall use its Commercially Reasonable Efforts to progress such Backup Compound through to completion of the PoC Study or [ * ] Study, as applicable under the relevant provisions of Articles 2 and 3.

 

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2.7.2 Phase I Ready Criteria . In the event that a Compound achieves [ * ] of the Phase I Ready Criteria after Dynavax has completed the activities required to make such an assessment, it being understood by the Parties that drug discovery is an iterative problem-solving process, and that multiple Compounds may be expected to be progressed in order to identify a Compound that merits advancement into clinical Development, Dynavax shall promptly notify GSK in writing of such event and shall provide to the JSC a complete data package containing all analyses, results and raw data from the Dynavax Program for such Compound (the “ Phase I Ready Report ”). Unless otherwise agreed to by the Parties, the JSC will schedule an ad hoc meeting not more than [ * ] after receipt by GSK’s JSC representatives of any such complete Phase I Ready Report to review such Phase I Ready Report and to confirm whether or not such Compound meets [ * ] of the Phase I Ready Criteria.

(a) If the JSC agrees that such Compound has achieved [ * ] of the Phase I Ready Criteria, then if such Compound is [ * ] , the Parties shall determine whether GSK shall [ * ] as to such Dynavax Program pursuant to [ * ] .

(b) If the JSC fails to agree that the Compound has satisfied [ * ] of the Phase I Ready Criteria, then the matter shall be resolved by [ * ] of the Phase I Ready Criteria have been met, then Dynavax shall complete any additional studies as are necessary [ * ] the Phase I Ready Criteria and progress such Compound through completion of the PoC study or [ * ] Study, as applicable under the relevant provisions of Articles 2 and 3. If the achievement of such criteria is not [ * ] , Dynavax shall instead progress a Backup Compound in place of the Compound that failed to meet the criteria, and Dynavax shall use its Commercially Reasonable Efforts to progress such Backup Compound through to completion of the PoC Study or [ * ] Study, as applicable under the relevant provisions of Articles 2 and 3.

(c) If either (i) the JSC agrees that such Compound has [ * ] of the Phase I Ready Criteria, and GSK either [ * ] in accordance with the applicable provisions of this Agreement, or (ii)  [ * ] of the Phase I Ready Criteria, and GSK either [ * ] in accordance with the applicable provisions of this Agreement, then Dynavax shall progress such Compound into a Phase 1 Clinical Trial [ * ] . A Compound that either the JSC, [ * ] of the Phase I Ready Criteria shall be considered to be at the “Phase I Ready” stage.

2.7.3 [ * ] Criteria . Upon the completion of any [ * ] Study, Dynavax shall promptly notify GSK in writing of such event and shall provide to the JSC a complete data package containing all analyses, results and raw data from the completion of the [ * ] Study for such Phase I Ready Compound, and any related correspondence and information received from or sent to any Regulatory Authority relating to such Phase I Ready Compound (the “ [ * ] Study Report ”). GSK shall [ * ] upon the completion of the [ * ] Study pursuant to [ * ] . Unless otherwise agreed by the Parties, if requested by GSK, the JSC will schedule an ad hoc meeting not more than [ * ] after receipt of any such [ * ] Study Report to review such [ * ] Study Report

 

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and confirm whether or not such Phase I Ready Compound satisfies the [ * ] Criteria. If the JSC (or the Executive Officers or GSK pursuant to Section 3.1.4(c)) decides that the Phase I Ready Compound did not satisfy the [ * ] Criteria, then, except as provided in Section 5.3, [ * ] with respect to such Dynavax Program and GSK [ * ] with respect to such Dynavax Program at [ * ] . In the event that the Compound fails to satisfy the [ * ] Criteria after completion of the [ * ] Study, but GSK [ * ] to such Dynavax Program, and GSK determines to [ * ] Study, in such case [ * ] for such GSK Development Program shall all be [ * ] from the [ * ] otherwise applicable, and the applicable [ * ] . If at any time after [ * ] the Compound that [ * ] Study [ * ] , as applicable, then GSK shall [ * ] .

2.7.4 Proof of Concept Criteria . Upon the completion of any Proof of Concept Study, Dynavax shall promptly notify GSK in writing of such event and shall provide to the JSC a complete data package containing all analyses, results and raw data from the completion of the Proof of Concept Study for such Phase I Ready Compound, and any related correspondence and information received from or sent to any Regulatory Authority relating to such Phase I Ready Compound (the “ PoC Study Report ”). GSK shall have the right to exercise its Option to such Dynavax Program upon the completion of the Proof of Concept Study pursuant to Section 4.1 (whether or not such criteria have been satisfied). Unless otherwise agreed by the Parties, if requested by GSK, the JSC will schedule an ad hoc meeting not more than [ * ] Calendar Days after receipt of any such PoC Study Report to review such PoC Study Report and confirm whether or not such Phase I Ready Compound satisfies the Proof of Concept Criteria. If the JSC [ * ] decides that the Phase I Ready Compound did not satisfy the Proof of Concept Criteria, then, except as provided in Section 5.3, Dynavax will [ * ] with respect to such Dynavax Program, and GSK may, [ * ] . In the event that the Compound fails to satisfy the Proof of Concept Criteria after completion of the Proof of Concept Study, [ * ] which completed the PoC Study, in such case the [ * ] and all other [ * ] for such GSK Development Program shall all be [ * ] from the [ * ] otherwise applicable, and the applicable [ * ] . If at any time after Option exercise the Compound that completed the PoC Study [ * ] , as applicable, then GSK shall [ * ] .

2.8 [ * ]. During the [ * ] , the JSC will review the progress of each Dynavax Program and [ * ] . The JSC may, [ * ] decide to [ * ] Dynavax Program(s) [ * ] Dynavax Program(s) that [ * ] Dynavax Programs, [ * ] . For clarity, if prior to the exercise by GSK of an Option with respect to a given Dynavax Program, the JSC is not in agreement, [ * ] . All such decisions shall be based on [ * ] . Notwithstanding the above, after GSK exercises an Option with respect to a Dynavax Program, GSK may, [ * ] , GSK shall be obligated to [ * ] . For the purposes of determining whether there is [ * ] , the TLR 7/9 Program shall [ * ] (for example, if a Compound in the [ * ] is being progressed, then the [ * ] may be rendered [ * ] , either prior to or after Option exercise by GSK).

2.9 Reports. Dynavax shall provide written progress reports on the status of each Dynavax Program, including without limitation summaries of data associated with Dynavax’s Research and Development activities and a timetable for completion of the respective Dynavax Program. Dynavax shall provide such written report to JSC members at least [ * ] Business Days in advance of the applicable JSC meeting.

 

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2.10 Material Transfer. To facilitate the conduct of the Programs, either Party may provide to the other Party certain biological materials or chemical compounds, such as cell-based assays or specific Compounds, owned by or licensed to the supplying Party for use by the other Party in furtherance of the Development Plans (such materials or compounds provided hereunder are referred to, collectively, as “ Materials ”). Except as otherwise provided under this Agreement, all such Materials delivered to the other Party shall remain the sole property of the supplying Party, shall be used only in furtherance of the Programs and solely under the control of the other Party (or its Affiliates), shall not be used or delivered to or for the benefit of any Third Party without the prior written consent of the supplying Party, and shall not be used in Research or testing involving human subjects, unless expressly agreed. The Materials supplied under this Section 2.9 are supplied “as is” and must be used with prudence and appropriate caution in any experimental work, since not all of their characteristics may be known. For the avoidance of doubt, this Section 2.10 shall not apply to any materials and/or Compounds supplied to GSK by Dynavax in accordance with Section 4.3 pursuant to the exercise by GSK of its Option for a Dynavax Program.

2.11 Regulatory Matters; Compliance.

2.11.1 Compliance . Dynavax shall conduct all pre-clinical activities and Clinical Trials under this Agreement in good scientific manner and in compliance in all material respects with applicable laws, rules and regulations and all other applicable requirements of cGMP, good laboratory practice and current good clinical practice.

2.11.2 Data Integrity .

(a) Dynavax acknowledges the importance to GSK of ensuring that the Dynavax Programs are undertaken in accordance with the following good data management practices:

(i) data are being generated using sound scientific techniques and processes;

(ii) data are being accurately and reasonably contemporaneously recorded in accordance with good scientific practices by Persons conducting Research hereunder;

(iii) data are being analyzed appropriately without bias in accordance with good scientific practices; and

(iv) data and results are being stored securely and can be easily retrieved.

(b) Dynavax agrees that it shall use Commercially Reasonable Efforts to carry out the Dynavax Programs so as to collect and record any data generated therefrom in a manner consistent with the above requirements as set forth in subsection (a) above.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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2.11.3 Ownership . [ * ] all regulatory filings for Compounds [ * ] . Upon [ * ] with respect to a Dynavax Program, Dynavax shall [ * ] as soon as reasonably practicable of all regulatory filings for the resulting GSK Development Compounds (including Back-up Compounds), including all relevant INDs, and provide GSK with copies of such INDs and other regulatory filings and all pre-clinical and clinical data and results (including pharmacology, toxicology, formulation, and stability studies). Thereafter, [ * ] and maintain all regulatory filings and Regulatory Approvals for GSK Development Compounds.

2.11.4 Adverse Event Reporting . Beginning on the Effective Date and continuing until such time, if any, that GSK exercises its Option with respect to a Dynavax Program, Dynavax shall be responsible for reporting all adverse drug reaction experiences related to Compounds in such Dynavax Program in connection with the activities of Dynavax under this Agreement to the appropriate Regulatory Authorities in the countries in the Territory in which such Compounds are being Developed, in accordance with the appropriate laws and regulations of the relevant countries and Regulatory Authorities. Dynavax shall provide GSK notice of such event within five (5) days and provide copies of all reports to GSK as soon as possible, including using Commercially Reasonable Efforts to provide such copies. Through the JSC, GSK shall have the right to review from time to time Dynavax’s pharmacovigilance policies and procedures. GSK and Dynavax agree to cooperate and use good faith efforts to ensure that Dynavax’s adverse event database is organized in a format that is compatible with GSK’s adverse event databases.

2.12 Dynavax Program Costs. Except as set forth in this Article 2, [ * ] shall [ * ] in connection with performing activities under a Dynavax Program.

2.13 Subcontracting. Subject to the terms of this Agreement, each Party shall have the right to engage Affiliates or Third Party subcontractors to perform certain of its obligations under this Agreement. Any Affiliate or subcontractor to be engaged by a Party to perform a Party’s obligations set forth in the Agreement shall meet the qualifications typically required by such Party for the performance of work similar in scope and complexity to the subcontracted activity. Notwithstanding the preceding, any Party engaging an Affiliate or subcontractor hereunder shall remain principally responsible and obligated for such activities. In addition, each Party engaging a subcontractor with respect to its obligations under a Dynavax Program shall in all cases retain or obtain exclusive Control of any and all intellectual property created by or used with the relevant Party’s permission by such subcontractor directly related to such subcontracted activity under the Dynavax Program. The Party engaging a subcontractor under a Dynavax Program shall be solely responsible for all costs associated with obtaining such exclusive Control and rights to such intellectual property. For example and not by limitation, Dynavax shall ensure that it retains or obtains exclusive Control of any intellectual property created by or used with the relevant Party’s permission by any academic or any contract research, manufacturing or development organization appointed by Dynavax to fulfill any of its obligations under this Agreement. However, it is understood that, in some cases, it may not be commercially reasonable for such Party [ * ] . To the extent that such [ * ] from any such subcontractor under a Dynavax Program, prior to entering into such arrangement with such

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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subcontractor, such Party shall bring such matter to the JSC for the prior approval of the JSC to enter into such arrangement and for approval by the JSC of the licensing terms and conditions with respect to such arrangement.

ARTICLE 3

MANAGEMENT OF THE COLLABORATION

3.1 Joint Steering Committee. Promptly and in any event within [ * ] days after the Effective Date, the Parties shall establish a committee (the “ Joint Steering Committee ” or “JSC” ) as more fully described in this Section 3.1. The JSC shall have review, oversight and decision-making responsibilities for all Research and Development activities performed under this Agreement, as more specifically provided herein. Each Party agrees to keep the JSC informed of its progress and activities under the Programs.

3.1.1 Membership . The JSC shall be comprised of three (3) representatives (or such other number of representatives as the Parties may agree) from each of GSK and Dynavax. Each Party shall provide the other with a list of its initial members of the JSC no later than thirty (30) days prior to the first scheduled meeting of the JSC, which shall be no later than ninety (90) days after the Effective Date. Each Party may replace any or all of its representatives on the JSC at any time upon written notice to the other Party in accordance with Section 13.7 of this Agreement. Each representative of a Party shall have relevant expertise (either individually or collectively) in pharmaceutical drug discovery and development. Any member of the JSC may designate a substitute to attend and perform the functions of that member at any meeting of the JSC. Each Party may, in its reasonable discretion, invite non-member representatives of such Party to attend meetings of the JSC as non-voting participants, subject to the confidentiality obligations of Article 9. The Parties shall designate a chairperson (each, a “ Chairperson ”) to oversee the operation of the JSC and prepare minutes as set forth in Section 3.1.3, each such Chairperson to serve a twelve (12) month term. The right to name the Chairperson shall alternate between the Parties, with [ * ] designating the first such Chairperson.

3.1.2 Meetings . During the Research Term, the JSC shall meet in person or otherwise at least once each Calendar Quarter, and more or less frequently as the Parties mutually deem appropriate, on such dates and at such places and times as provided herein or as the Parties shall agree. Subject to Section 5.5, upon conclusion of the Research Term, the JSC shall meet, in person or otherwise, at least once every Calendar Year to provide Dynavax an update regarding GSK’s efforts to Develop and commercialize Compounds and GSK Products in the GSK Development Programs, including without limitation, material changes in the clinical development plans for GSK Products, status of regulatory filings, anticipated indications, anticipated launch dates, manufacturing issues, and the like. Meetings of the JSC that are held in person shall alternate between the offices of the Parties, or such other place as the Parties may agree. The members of the JSC also may convene or be polled or consulted from time to time by

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. Each Party will bear all expenses it incurs in regard to participating in all meetings of the JSC, including all travel and living expenses.

3.1.3 Minutes . The Alliance Manager from the Party other than the Party of the Chairman, shall be responsible for preparing and circulating minutes of each meeting of the JSC, setting forth, inter alia , an overview of the discussions at the meeting and a list of any actions, decisions or determinations approved by the JSC and a list of any issues to be resolved by the Executive Officers pursuant to Section 3.1.4. Such minutes shall be effective only after approved by both Parties. With the sole exception of specific items of the meeting minutes to which the members cannot agree and that are escalated to the Executive Officers as provided in Section 3.1.4 below, definitive minutes of all JSC meetings shall be finalized no later than thirty (30) days after the meeting to which the minutes pertain. If at any time during the preparation and finalization of the JSC minutes, the Parties do not agree on any issue with respect to the minutes, such issue shall be resolved by the escalation process as provided in Section 3.1.4. The decision resulting from the escalation process shall be recorded by the Alliance Manager in amended finalized minutes for such meeting.

3.1.4 Decisions . Except as otherwise provided herein, with respect to a given Program, all decisions of the JSC prior to Option exercise by GSK shall be made by [ * ] , with each Party having [ * ] . In the event that the JSC [ * ] on a matter regarding a Dynavax Program within [ * ] Calendar Days after it has met and attempted to reach such decision, then, except for matters expressly identified in this Agreement as not subject to escalation to the Executive Officers pursuant to this Section 3.1.4, either Party may, by written notice to the other, have such issue referred to [ * ] from time to time [ * ] , for resolution. [ * ] , which shall in no case be more than [ * ] after the matter was referred to [ * ] , the issue shall be finally resolved as follows:

(a) [ * ] shall have final decision-making authority with respect to any disputes concerning [ * ] .

(b) If the dispute concerns whether [ * ] , the disputed issue shall be [ * ] .

(c) GSK shall have final decision-making authority with respect to any disputes concerning [ * ] .

3.1.5 Responsibilities . The JSC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 3.1.4(a), (b) and (c), some or all of which may be addressed directly at any given meeting of the JSC:

(a) review and comment on the Development Plan for each Dynavax Program and monitor progress of activities under such Development Plan;

 

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(b) oversee and guide the progress of each Dynavax Program in accordance with the applicable Pre-Candidate Selection Criteria, Phase I Ready Criteria, [ * ] Criteria and Proof of Concept Criteria;

(c) [ * ] ;

(d) prepare, review, modify, update and approve each Proof of Concept Study Design and [ * ] Study Design;

(e) identify the Dynavax Programs to be conducted by Dynavax under this Agreement;

(f) assess the Proof of Concept Criteria and, if applicable, the [ * ] Criteria, for each Dynavax Program;

(g) [ * ] that a Compound has satisfied the Pre-Candidate Selection Criteria, Phase I Ready Criteria, Proof of Concept Criteria, or [ * ] Criteria;

(h) [ * ] all Dynavax Programs and decide whether to [ * ] a Dynavax Program;

(i) except as otherwise provided in Section 3.1.8 below, discuss and attempt to resolve any deadlock issues submitted to it by any Subcommittee (as defined in Section 3.1.7), in accordance with the procedures established in Section 3.1.4;

(j) serve as an information transfer vehicle, from time to time, to facilitate the discussion of Development and commercialization of GSK Products under GSK Development Programs;

(k) periodically review the Development and commercialization of any GSK Product and GSK Development Plan and [ * ] ; and

(l) such other responsibilities as may be assigned to the JSC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time.

For clarity, the JSC shall not have any authority beyond the specific matters set forth above in this Section 3.1.5, and in particular shall not have any power to amend or modify the terms or provisions of this Agreement. In addition, GSK (and not Dynavax or the JSC) shall have the sole right to make decisions with respect to (i) the exercise of an Option; or (ii) subject to Section 5.5 and GSK’s diligence obligations in Section 5.1.3, the Research, Development, progression, manufacture, and commercialization of Compounds or Products in GSK Development Programs.

3.1.6 Dynavax’s Right to Withdraw . Dynavax will have the right to withdraw from participation on and thereby terminate any of its rights and obligations to participate in the JSC at any time after the [ * ] anniversary of the Effective Date upon written notice to GSK.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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Upon withdrawal by Dynavax from participation in the JSC, GSK will have the sole decision-making authority with respect to any matters that would otherwise have been subject to Sections 3.1.4(a) or 3.1.4(b) and GSK shall have the right in such event, in its sole discretion, to immediately terminate all of Dynavax’s Co-Development and Co-Promotion rights, whether previously exercised or not, under this Agreement.

3.1.7 Subcommittee(s). From time to time, the JSC may establish subcommittees to oversee particular projects or activities, as it deems necessary or advisable (each, a “ Subcommittee ”). Each Subcommittee shall consist of such number of members as the JSC determines is appropriate from time to time. Such members shall be individuals with expertise and responsibilities in the areas of pre-clinical development, clinical development, patents, process sciences, manufacturing, regulatory affairs, product development and/or product commercialization, as applicable to the stage of development of the project or activity.

3.1.8 Joint Patent Subcommittee . Within two (2) months after the Effective Date, the JSC shall establish a Subcommittee (the “Joint Patent Subcommittee” or “JPS” ) to be responsible for the coordination of the Parties’ efforts in accordance with Article 8 of this Agreement, including the review and filing of patent applications and assessments of inventorship of inventions created during the Research Term under the Dynavax Programs. The JPS shall be comprised of an equal number of representatives from each of GSK and Dynavax and shall meet on such dates and at such places and times agreed to by the Parties. All decisions of the JPS on matters for which it has responsibility shall be made by consensus, with each Party having collectively one (1) vote in all decisions. In the event that the JPS is unable to reach a consensus decision within fifteen (15) Calendar Days after it has met and attempted to reach such decision, then either Party may, by written notice to the other, have such issue submitted to the chief patent counsel of GSK and of Dynavax (together, the “Chief Patent Counsel” ), or such other person holding a similar position designated by GSK or Dynavax from time to time, for resolution. The Chief Patent Counsel shall meet promptly to discuss the matter submitted and to determine a resolution. Prior to exercise of an Option for a Dynavax Program, if the Chief Patent Counsel are unable to determine a resolution in a timely manner: (a) with respect to [ * ] related to such Program, then the decision of the chief patent counsel [ * ] shall be binding upon the Parties without further review, and (b) with respect to [ * ] related to such Program, then the decision of the chief patent counsel of [ * ] shall be binding upon the Parties without further review. Each Party will bear all expenses it incurs in regard to participating in all meetings of the JPS, including all travel and living expenses. After exercise of an Option hereunder for a Dynavax Program, if the Chief Patent Counsel are unable to determine a resolution in a timely manner with respect to any Patents related to such Program, [ * ] .

3.2 Alliance Managers. Promptly after the Effective Date, each Party shall appoint an individual (who may not be an existing member of the JSC) to act as alliance manager for such Party (each, an “ Alliance Manager ”). Each Alliance Manager shall thereafter be permitted to attend meetings of the JSC as a nonvoting observer, subject to the confidentiality provisions of Article 9. The Alliance Managers shall be the primary point of contact for the Parties regarding the activities contemplated by this Agreement and shall facilitate all such activities hereunder

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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including, but not limited to, the exchange of Information described in Section 2.9. The Alliance Managers shall also be responsible for assisting the JSC in performing its oversight responsibilities. The name and contact information for each Party’s Alliance Manager, as well as any replacement(s) chosen by Dynavax or GSK, in their sole discretion, from time to time, shall be promptly provided to the other Party in accordance with Section 13.7 of this Agreement.

ARTICLE 4

GRANT OF RIGHTS

4.1 Options.

4.1.1 Grant . Dynavax hereby grants to GSK the exclusive option, exercisable on a Dynavax Program-by-Dynavax Program basis at GSK’s sole discretion, to obtain the exclusive license set forth in Section 4.2.1 (each, an “ Option ”), subject to the terms and conditions described in Sections 4.1.2—4.1.6 below. GSK shall be limited to exercising one Option per Dynavax Program, and on exercise of an Option and payment of the applicable Option exercise fee, GSK shall have rights to such Dynavax Program consisting of all Compounds under a given Dynavax Program. For the purposes of this Section 4.1, the [ * ] and the [ * ] shall be considered distinct Dynavax Programs, each subject to a separate Option.

4.1.2 [ * ] Period . For the two (2) Dynavax Programs other than [ * ] , the Parties will determine whether GSK may exercise the Option [ * ] after a Phase I Ready Compound has completed the [ * ] Proof of Concept Study, as applicable, as follows. Within [ * ] after the JSC determines that a Compound has reached the Phase I Ready stage pursuant to Section 2.7.2(a), the Parties shall [ * ] or Dynavax shall [ * ] , as applicable. If the Parties do not agree within such [ * ] period, or if the Parties do agree that [ * ] , as applicable, then Dynavax shall continue to progress the Dynavax Program, and the Option for such Dynavax Program may be exercised only following completion of [ * ] the Proof of Concept Study, as applicable; provided , however, that if in GSK’s reasonable judgment as specified in a reasonably detailed written notice to Dynavax delivered within [ * ] after attainment of the Phase I Ready stage, Dynavax does not [ * ] , as applicable, then GSK [ * ] . For clarity, GSK may exercise the Option with respect to the TLR 7/9 Program under any of the following circumstances, at the sole discretion of GSK, but in any event [ * ] : (i) after completion of the [ * ] or Proof of Concept Study, as determined pursuant to Section 2.6.3, or (ii) pursuant to Section 4.1.3(b) or 4.1.3(c).

4.1.3 Exercise .

(a) The “Option Period Start” with respect to a Dynavax Program will commence upon the receipt by GSK of written notice from Dynavax of the complete PoC Study Report, complete [ * ] Study Report, or [ * ] , as the case may be, as well as access to GSK to the Dynavax data room containing the complete set of material or relevant clinical and

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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preclinical information related to the applicable Dynavax Program. GSK shall decide whether or not to exercise the Option and may exercise the Option with respect to a Dynavax Program by written notice to Dynavax at any time within [ * ] after the Option Period Start, unless extended pursuant to Section 4.1.5 or otherwise extended by the mutual written agreement of the Parties. Upon GSK’s exercise of an Option and receipt by Dynavax of the applicable Option exercise fee set forth in Section 6.2.1(a) or 6.2.2(a) pursuant to the procedure set forth in Section 6.7, the Dynavax Program will become a GSK Development Program. Subject to Section 5.3.2, any Option exercise shall be irrevocable. GSK shall have the right, at any time after exercising the Option with respect to a Dynavax Program and at its sole discretion, to [ * ] from the same Dynavax Program.

(b) In addition, in the event that either (i) a [ * ] , or (ii) a [ * ] occurs (as defined below), GSK shall have the right to exercise its Options to any and all Dynavax Programs, and to terminate Dynavax’s [ * ] rights to participate in the JSC and related Subcommittees, at GSK’s sole discretion, by providing written notice to Dynavax within [ * ] of (A) the event described in (i) above; or (B) the event described in (ii) above, provided that within [ * ] Business Days after Dynavax notifies GSK pursuant to Section 10.2.9, Dynavax shall provide to GSK a written plan for [ * ] and the Parties shall meet to discuss such plan, and if such plan is not reasonably acceptable to GSK (as reasonably detailed in written notice to Dynavax) then a [ * ] shall have occurred. Upon the exercise by GSK of its Option to a Dynavax Program pursuant to this Section 4.1.3(b), the Option exercise fee and the applicable milestone payments and royalty payments due under Article 6 shall all be [ * ] as follows on a Program-by-Program basis for each Program with respect to which GSK exercises its Option:

(1) if Option exercise occurs for a Dynavax Program with a lead Compound (other than the [ * ] ) that has not yet satisfied the Pre-Candidate Selection Criteria, then the Option exercise fee and the milestone and royalty payments shall be [ * ] ;

(2) if Option exercise occurs for a Dynavax Program with a lead Compound that has satisfied the Pre-Candidate Selection Criteria but is prior to the Phase I Ready stage, then the Option exercise fee and the milestone payments and the royalty payments either (i) shall be [ * ] , for a Program other than [ * ] , or (ii) shall be [ * ] .

(3) if Option exercise occurs for a Dynavax Program with a lead Compound at the Phase I Ready stage, but prior to initiation of a Phase 2 Clinical Trial, then the Option exercise fee and the milestone payments and royalty payments shall all be [ * ] from the payments that would have been payable under Article 6 had GSK exercised its Option after completion of the Proof of Concept Study;

(4) if Option exercise occurs for a Dynavax Program after the initiation of a Phase 2 Clinical Trial for such Program, then the Option exercise fee and the milestone payments and royalty payments shall be [ * ] that would have been payable under Article 6 had GSK exercised its Option after the Proof of Concept Study; and

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(5) if Option exercise occurs for a Dynavax Program pursuant to Section 4.1.3(b)(ii) wherein Dynavax has [ * ] (i) within [ * ] of the Effective Date of this Agreement, then, [ * ] above of this Section 4.1.3(b), in the total amount of [ * ] , and, if such Option exercise occurs (ii) more than [ * ] after the Effective Date but prior to [ * ] after the Effective Date of this Agreement, then, [ * ] above of this Section 4.1.3(b), in the total amount of [ * ] .

The respective obligations of the Parties with respect to exclusivity under Article 7 shall remain unchanged.

(c) In the event that a [ * ] , then within [ * ] after the [ * ] , and quarterly thereafter, the Parties and the acquiror shall meet to discuss, in good faith and in as much detail and specifics as is practicable at the time, [ * ] under this Agreement. If at any time in the [ * ] following the [ * ] , GSK has a reasonable, good faith basis to believe, based on the plans, documents, actions or inactions of Dynavax [ * ] that Dynavax [ * ] has not or will not, with respect to any Program, employ diligent efforts or human and material resources that are at least equivalent to the diligent efforts and human and material resources that were employed by Dynavax for the Program prior to (and without any allowance for) any delay, disruption or de-prioritization of such Program as a result of or in contemplation of such [ * ] , then GSK shall provide written notice to Dynavax [ * ] , such notice to allege the specific basis for GSK’s view that the diligent efforts or human and material resources being applied or to be applied to the Program in question are or are expected to be less than those that were applied to the Program by Dynavax [ * ] . Dynavax [ * ] shall notify GSK whether or not it plans to cure such deficiency, and if it so elects to cure, shall have a [ * ] to cure any such deficiencies in efforts or resources so alleged by GSK. In the event that Dynavax [ * ] notifies GSK that it does not intend to cure such deficiencies or GSK reasonably believes that such deficiency has not been corrected or cured within such [ * ] , GSK shall have the right to exercise its Options to any and all Dynavax Programs, and to terminate Dynavax’s [ * ] rights to participate in the JSC and related Subcommittees, at GSK’s sole discretion, by providing written notice to Dynavax within thirty (30) days after such [ * ] or such notice from Dynavax [ * ] . Upon the exercise by GSK of its Option to a Dynavax Program pursuant to this Section 4.1.3(c), the Option exercise fee and the applicable milestone payments and royalty payments due under Article 6 shall all be [ * ] as set forth in Section 4.1.3(b)(1)-(5) as applicable, on a Program-by-Program basis for each Program with respect to which GSK exercises its Option.

4.1.4 Expiration or Termination of Option . If GSK does not exercise the Option with respect to a particular Dynavax Program within the applicable [ * ] or GSK elects not to exercise the Option, then, subject to Section 4.1.5, the Option shall terminate with respect to such Dynavax Program, which shall become a Dynavax Development Program, and Dynavax will thereafter have all rights, itself or with or through an Affiliate or Third Party, (a) to Develop and commercialize all Compounds within the Dynavax Program, subject to any applicable royalty payments set forth in Section 6.5, and (b) to use any data, regulatory filings and know-how generated or used in the course of the Dynavax Program, to the extent such [ * ] that are included in the Dynavax Development Program.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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4.1.5 HSR and Equivalent Foreign Laws. If GSK reasonably determines in good faith prior to the expiration of the applicable period for exercise of an Option for a particular Dynavax Program (the “ Option Deadline Period ”) that the exercise of such Option is required to be filed with the Federal Trade Commission (the “ FTC ”) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (15 U.S.C. §18a) (“ HSR ”) or with equivalent foreign governmental authorities under any similar foreign law, GSK shall provide written notice of exercise of the Option to Dynavax prior to the end of the Option Deadline Period, which notice shall include GSK’s binding commitment to complete the exercise of the Option, subject only to HSR or other governmental clearance by the FTC or other governmental authority, and the Option Deadline Period automatically shall be extended for [ * ] (the “ Option Deadline Extension Period ”). If the exercise of the Option does not comply with the requirements of Section 4.1 and this Section 4.1.5, including, for example, because it includes other conditions to the completion of the exercise of the Option other than the grant of HSR or other governmental clearance, then the Parties shall negotiate in good faith to determine an appropriate way to proceed. If HSR or other governmental clearance is not granted within the Option Deadline Extension Period, or if GSK receives a “Second Request” from the FTC or similar request for additional information from a governmental authority in connection with such filing, the Option Deadline Extension Period shall be extended for an additional period of time (not to exceed an additional [ * ] ) to permit GSK to obtain FTC or other governmental clearance or to respond to the Second Request or provide additional information to the governmental authority. If GSK elects not to respond to the Second Request or to withdraw its request for HSR or other governmental clearance or HSR, the Option shall terminate, and Dynavax shall have the same rights as are set forth in Section 4.1.4 in respect of the Compounds resulting from the applicable Dynavax Program. If HSR or other governmental clearance has not been granted by the end of the extended Option Deadline Extension Period, Dynavax and GSK shall promptly meet to discuss in good faith whether an additional extension of the Option Deadline Extension Period is reasonable under the circumstances, and to discuss and consider in good faith, where appropriate, the [ * ] , with the objective of placing each Party [ * ] if the Program in question had not been included in the Agreement from the beginning as of the Effective Date. Notwithstanding the foregoing, nothing in this paragraph or the Agreement shall require either Party to divest any assets or to take action (beyond cooperation with the other Party) to respond to any Second Request.

4.1.6 Tolling of Payment Obligations . If the exercise by GSK of any Option under Section 4.1 requires the making of filings under HSR, or under any similar premerger notification provision in the European Union or any other jurisdiction, then all rights and obligations related to the exercise of such Option (including payment of any Option exercise fee or other milestone) shall be tolled until the applicable waiting period has expired or been terminated or until approval or clearance from the reviewing authority has been received, and each Party agrees to cooperate at the request of the Party which decides in its sole discretion to respond to any such request for information to expedite review of such transaction. In the event that HSR clearance is not reasonably achievable within [ * ] days from notification, the Parties shall discuss in good faith potential alternatives, including, without limitation, termination of the relevant Program or the Agreement, as may be mutually agreed between the Parties in good faith, and, where appropriate, to discuss and consider in good faith the renegotiation of their financial and other obligations under the Agreement with respect to the affected Program.

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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4.2 License Grants.

4.2.1 License to GSK . Subject to the terms and conditions of this Agreement and upon GSK’s exercise of the relevant Option in accordance with Section 4.1 and Dynavax’s receipt of the applicable Option exercise fee, Dynavax and its Affiliates shall be hereby deemed to have granted and hereby grant to GSK the exclusive right and license (even as to Dynavax and its Affiliates, except for the limited purpose of conducting Research and Development activities with respect to Back-up Compounds or formulations as expressly contemplated under Section 5.2) in the Territory, with the right to grant sublicenses, under all of Dynavax’s and its Affiliates’ right, title and interest in and to the Exclusively Licensed IP to make, have made, use, sell, offer for sale and import Compounds under such Dynavax Program as and into GSK Products in the Field during the Term.

4.2.2 No Grant of Rights to Third Parties . Until such time as the Option Deadline Period, including any Option Deadline Extension Period (as may be extended), for an Option granted to GSK pursuant to Section 4.1 with respect to a given Dynavax Program has expired or terminated (including, for example, because [ * ] terminated a Dynavax Program), Dynavax and its Affiliates shall not grant to any Third Party rights to any Exclusively Licensed IP that are inconsistent with or that would interfere with the grant of the licenses that may result from the exercise of such Option by GSK hereunder. For the avoidance of doubt, the Parties understand and agree that for so long as an Option is in effect, such Option shall be exclusive as to the Compounds that are the subject of the relevant Dynavax Program, and Dynavax and its Affiliates shall have no right to offer or negotiate with any Third Party with respect to the grant to such Third Party of any right or license, or with respect to any settlement, consent judgment or other disposition of any action or proceeding under Article 8, or with respect to any other encumbrance of any kind, in or to any of such Compounds or any Exclusively Licensed IP that would interfere with the grant of the licenses resulting from the exercise of such Option to GSK hereunder. The grant of the Options by Dynavax hereunder is irrevocable except as provided under Article 12. GSK acknowledges that certain of the Exclusively Licensed IP to the extent that it pertains to compounds which are not Compounds or Products hereunder is subject to the terms and conditions of the [ * ] and that such grant of rights, so long as such grant is consistent with and does not interfere with the grant of exclusive licenses in the Field and in the Territory from the exercise of an affected Option hereunder, shall not be deemed a breach of this Agreement.

4.3 Technology Transfer after Option Exercise. As soon as reasonably practicable after GSK exercises its Option for a Dynavax Program pursuant to Section 4.1 [ * ] , Dynavax shall deliver to GSK, at no cost to GSK, all Information and material in its possession and Control relating to the Compounds in such GSK Development Program, including those documents and materials set out in Exhibit G, and any other such Information as may be in Dynavax’s Control and in the possession of any subcontractors (including third party

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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manufacturers) appointed by Dynavax under Section 2.13, in each case in a format to be agreed between the Parties but which is in an electronically editable format suitable for eCTD submission. Dynavax shall provide such technology transfer services as may be reasonably necessary to [ * ] the Compound manufacturing processes at GSK’s or GSK’s Third Party manufacturer’s site; provided that GSK shall be responsible for [ * ] to provide those services reasonably necessary to [ * ] of the Compound manufacturing processes by GSK, and [ * ] from Dynavax therefor. [ * ]. Dynavax shall use Commercially Reasonable Efforts with respect to those activities for which it is responsible to ensure orderly transition and uninterrupted Development of the GSK Development Program.

4.4 Third Party Licenses.

4.4.1 During the Term, [ * ] (a) required for the exploitation of Dynavax’s proprietary platform technology or any other technology used by Dynavax in conducting a Dynavax Program or Dynavax Development Program, (b) obtained by Dynavax prior to the Effective Date, or (c) to the extent related to the composition of matter or method of use of a Compound as contemplated under a Dynavax Program.

4.4.2 With respect to any Third Party license necessary for the manufacture, formulation or commercialization of a GSK Product in a GSK Development Program (other than any license described in Section 4.4.1), after GSK exercises the Option with respect to such GSK Development Program, [ * ] obligation to pay any amounts for Third Party licenses as set forth above shall terminate immediately if GSK or Dynavax (in the case of an uncured material breach by GSK) [ * ] .

ARTICLE 5

POST-EXERCISE ACTIVITIES

5.1 GSK Development and Commercialization.

5.1.1 Following exercise of an Option with respect to a Dynavax Program, subject to Sections 5.2 and 5.5, GSK, either itself and/or by and through its Affiliates, Sublicensees or contractors, shall be responsible for all Research, Development, regulatory, manufacturing, marketing, advertising, promotional, launch and sales activities in connection with GSK Products containing Compounds from such Program. Except as set forth in Section [ * ] .

5.1.2 Subject to Section 5.5.1(c), GSK shall have sole decision-making authority with respect to the Research, Development, progression, regulatory activities, manufacturing and commercialization of any Compound within a GSK Development Program, without submitting such matter to the JSC or Senior Executive Officers. In the event that the [ * ] for resolution. [ * ] determine a resolution. [ * ] in a timely manner, which shall in no case be [ * ] .

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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5.1.3 GSK Diligence.

(a) Following GSK’s exercise of an Option with respect to a Dynavax Program, GSK shall use its Commercially Reasonable Efforts to Develop and commercialize [ * ] in such GSK Development Program in [ * ] , subject to the provisions of Section 2.8. [ * ] provided, however, that the Parties acknowledge and agree that, for the purposes solely of this Section 5.1.3(a), [ * ] , it is appropriate for [ * ] . In the event that, as a result of any such [ * ] Country, such right of Dynavax shall be exercised in a manner [ * ] (collectively, the “ Coordination Conditions ”); provided that if the Coordination Conditions apply, if such Product is commercialized by Dynavax or any Affiliate or sublicensee thereof in such country [ * ] , and GSK [ * ] , then Dynavax or any Affiliate or licensee thereof shall, to the extent permitted under applicable law, [ * ] , as the case may be, or shall [ * ] under this Section 5.1.3 in [ * ] . For clarity, and without limiting any other provision of this Agreement, any dispute regarding the application or enforcement of this Section 5.1.3 shall be [ * ] .

(b) Notwithstanding the foregoing Section 5.1.3(a) and for the avoidance of doubt, Dynavax acknowledges and agrees that in the event it (or its Affiliates or sublicensee) commercializes a Product [ * ] then, subject to applicable law, Dynavax shall not, and shall ensure that its Affiliates or any sublicensee shall not, [ * ] unless mutually agreed in writing by the Parties, provided that [ * ] . With respect to [ * ] . If Dynavax (or its Affiliate or licensee) becomes aware that [ * ] , Dynavax shall, or shall cause its Affiliates and licensees to, to the extent permitted under applicable law, [ * ] .

5.2 Dynavax Post-Exercise Activities.

5.2.1 Back-up Compounds . If, upon exercise of the Option with respect to a Dynavax Program, there are not [ * ] Back-up Compounds in such Dynavax Program that [ * ] , then Dynavax shall continue, until [ * ] after GSK exercises such Option, to Develop [ * ] Back-up Compounds that [ * ] for such Dynavax Program, at Dynavax’s sole cost and responsibility. Such Back-up Compounds shall be subject to GSK’s Option and included within the applicable GSK Development Program. For clarity, efforts undertaken pursuant to this Section 5.2.1 following expiration of the Research Term shall not be deemed to extend the Research Term, but shall be subject to Dynavax’s obligation to use Commercially Reasonable Efforts.

5.2.2 [ * ] Development . If, after completion of a Proof of Concept Study for a Phase I Ready Compound from a Dynavax Program or GSK Development Program, Dynavax has not [ * ] for such Compound for [ * ] in the applicable Development Plan, then Dynavax shall continue to develop such [ * ] , at its sole cost and expense, notwithstanding GSK’s exercise of the Option for the Dynavax Program; provided , however, that an [ * ] of a Compound that is [ * ] shall be considered a [ * ] , provided that it meets GSK’s then current requirements for [ * ] .

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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