LICENSE AGREEMENT

Exhibit 10.2

 

LICENSE AGREEMENT

Supersedes and replaces Collaboration Agreement

T HIS L ICENSE A GREEMENT (the “Agreement” ), effective as of February 25, 2009 (the “Effective Date” ), is entered into by and between C ELLADON C ORPORATION , a California corporation ( “Celladon” ), with its principal place of business at 2223 Avenida de la Playa, Suite 300, c/o Enterprise Partners Venture Capital, La Jolla, CA 92037, and T ARGETED G ENETICS C ORPORATION , a Washington corporation ( “TGC” ), with its principal place of business at 1100 Olive Way, Suite 100, Seattle, WA 98101.

R ECITALS

W HEREAS , Celladon and TGC are parties to that certain Collaboration Agreement dated December 31, 2004, as amended to date (the “Collaboration Agreement” ), pursuant to which the parties established a collaborative relationship relating to Celladon’s cardiac gene therapy product candidate;

W HEREAS , Celladon and TGC have determined that it is in the best interests of both parties that the collaborative relationship between them be converted into a licensing arrangement;

W HEREAS , Celladon and TGC intend that this Agreement supersede and replace the Collaboration Agreement in its entirety, effective as of the Effective Date;

W HEREAS , concurrently herewith, Celladon and TGC are entering into that certain Amended and Restated Manufacturing Agreement dated as of the Effective Date (the “Manufacturing Agreement” ), which supersedes and replaces the Manufacturing Agreement between the parties dated December 31, 2004, as amended to date (the “2004 Manufacturing Agreement” ), pursuant to which TGC will manufacture certain clinical trial bulk product for Celladon and perform certain other manufacturing services; and

W HEREAS , this Agreement and the Manufacturing Agreement will also supersede and replace the letter agreement between the parties dated January 16, 2009 (the “2009 Letter” ).

A GREEMENT

N OW , T HEREFORE , in consideration of the foregoing and the mutual promises and covenants hereinafter set forth, Celladon and TGC, intending to be legally bound, hereby agree as follows:

 

1.	D EFINITIONS .

1.1 “AAV Vector” shall mean an adeno-associated virus gene vector composed of a viral capsid comprising three proteins known as VP1, VP2 and VP3, wherein the genome is a single-strand DNA molecule flanked by inverted terminal repeats.

1.2 “Additional Materials” shall have the meaning provided in Section 2.2(c).

1.3 “Affiliate” shall mean any company or entity controlled by, controlling, or under common control with a party hereto and shall include any company more than 50% of whose voting stock or participating profit interest is owned or controlled, directly or indirectly, by a party, and any company which owns or controls, directly or indirectly, more than 50% of the voting stock of a party.

1.4 “Celladon Designee” shall have the meaning provided in the Manufacturing Agreement.

1.5 “Celladon Patents” shall mean, to the extent necessary or useful for the development, manufacture, use or sale of any Celladon Product, all Patents that Celladon or any of its Affiliates Controls as of the Effective Date or during the Term.

1.6 “Celladon Product” shall mean an AAV Vector-delivered product, the mechanism of action of which is [*] . Celladon Products include, without limitation, MYDICAR ^® (AAV1/SERCA2a). For the avoidance of doubt, any TGC Product for which rights revert back to TGC in accordance with Section 2.5 shall, upon such reversion, no longer be considered a Celladon Product for purposes of this Agreement.

1.7 “cGMP3” shall have the meaning provided in the Manufacturing Agreement.

1.8 “Claim” shall have the meaning provided in Section 8.1.

1.9 “Commercially Reasonable Efforts” means, with respect to the efforts to be expended by any entity with respect to any objective, the level of reasonable, diligent, good faith efforts and resources devoted to accomplish such objective as a typical biopharmaceutical company would normally use to accomplish a similar objective under similar circumstances. With respect to any objective relating to the commercialization of a Celladon Product by any entity, “Commercially Reasonable Efforts” means efforts and resources normally used by a typical biopharmaceutical company with respect to a product owned by such entity or to which such entity has similar rights that is of similar market potential at a similar stage in the development or life of such product, taking into account issues of safety, efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the product, the regulatory structure involved, profitability of the product and other relevant commercial factors.

1.10 “Competitive Threat” shall mean, with respect to a given product, that such product is reasonably expected to be developed for the same indication as a given Celladon Product and that commercialization of such product (taking into consideration both such indication and any reasonably anticipated off-label indication(s)) would reasonably be expected to materially reduce the sales of the applicable Celladon Product.

1.11 “Composition” shall mean the combination of a particular AAV Vector ( e.g. , AAV1) and a particular gene or other genetic construct that is intended to be delivered via such AAV Vector ( e.g. , the transgene).

1.12 “Confidential Information” shall have the meaning provided in Section 6.1.

 

1.13 “Control” shall mean, with respect to any Information, Patent or other intellectual property right, possession by a party of the right (whether by ownership, license or otherwise) to grant access, a license or a sublicense to such Information, Patent or intellectual property right without violating the terms of any agreement or other arrangement with any Third Party.

1.14 “Core TGC Patents” shall mean the TGC Patents and TGC Licensed Patents listed on Exhibit C and Exhibit D hereto, as may be amended from time to time in accordance with Section 4.1(e).

1.15 “Core Third Party Agreements” shall mean the Third Party Agreements listed on Exhibit B hereto, as such exhibit may be amended from time to time pursuant to Section 2.1(b) or by mutual written agreement of the parties.

1.16 “Core Third Party Agreement Information” shall mean, with respect to each Core Third Party Agreement:

(a) title and date of such Core Third Party Agreement (including any amendment(s) thereto);

(b) name of Third Party;

(c) description of TGC Licensed Technology licensed to TGC thereunder and the scope of such license;

(d) the amount, type and due dates of all [*] payments due or payable by TGC to such Third Party under such Core Third Party Agreement [*] (including development and commercialization of Celladon Products) pursuant to the license granted under Section 2.1(a) (collectively, such payment amounts for all Core Third Party Agreements, the “Third Party Payments” ); and

(e) all applicable reporting obligations under such Core Third Party Agreement associated with such Third Party Payments.

1.17 “[*] Material” shall have the meaning provided in the [*] Agreement.

1.18 “[*] Materials” shall have the meaning provided in the [*] Agreement.

1.19 “FDA” shall mean the United States Food and Drug Administration, or any successor agency thereto.

1.20 “Field” shall mean [*] .

1.21 “First Amendment” shall mean that certain First Amendment to Collaboration Agreement between the parties, dated June 19, 2006.

1.22 “First Amendment Arrangement” shall mean:

(a) any agreement between Celladon and any Third Party under which Celladon contracted for such Third Party to [*] , which agreement was entered into prior to the Effective Date

 

pursuant to Section 2.9(b) of the Collaboration Agreement, as set forth in paragraph 1 of the First Amendment;

(b) collectively, that certain [*] Agreement between TGC and the [*] ( “ [*] ” ) and that certain [*] Agreement between Celladon and [*] , which agreements were entered into prior to the Effective Date pursuant to Section 2.9(c) of the Collaboration Agreement, as set forth in paragraph 1 of the First Amendment; or

(c) any agreement by and among Celladon, TGC and a Third Party (including, without limitation, [*] ) entered into prior to the Effective Date pursuant to paragraph 2 of the First Amendment;

1.23 including, in each case, any amendment(s) to any of the foregoing, regardless of whether such amendment was entered into before or after the Effective Date. “First Commercial Sale” shall mean, with respect to a Celladon Product, the first sale for end use or consumption of such Celladon Product in a country after the governing health regulatory authority of such country has granted the first Regulatory Approval required therefor. Sale to an Affiliate or Licensee shall not constitute a First Commercial Sale unless the Affiliate or Licensee is the end user of the Product.

1.24 [*] shall mean [*]

1.25 “[*] Agreement” shall mean that certain [*] Agreement among Celladon, TGC and [*] dated August 6, 2008.

1.26 “IND” shall mean an Investigational New Drug Application filed with the FDA, or the equivalent application or filing filed with any equivalent agency or governmental authority outside the United States of America (including any supra-national agency such as in the European Union) necessary to commence human clinical trials in such jurisdiction.

1.27 “Information” shall mean all tangible and intangible (a) techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, know-how, skill, experience, test data and results (including pharmacological, toxicological and clinical test data and results), analytical and quality control data, results or descriptions, software and algorithms and (b) compositions of matter, cells, cell lines, assays, animal models and physical, biological or chemical material.

1.28 [*] shall mean [*]

1.29 “[*] Agreement” shall mean that certain [*] Agreement among Celladon, TGC and [*] dated September 15, 2006.

1.30 “Joint Invention” shall mean any invention, whether patentable or not, which is conceived or reduced to practice, before or after the Effective Date, jointly by one or more employees or contractors of Celladon and one or more employees or contractors of TGC.

1.31 “Lead Party” shall have the meaning provided in Section 4.3(a).

 

1.32 “Licensee” shall mean a Third Party to whom Celladon or any of its Affiliates has directly or indirectly ( i.e. , through the grant of a sublicense by a Third Party under a license granted to such Third Party by Celladon) granted a license or sublicense of the right to develop, make, have made, use, distribute for sale, promote, market, offer for sale, sell, have sold, import or export Celladon Products, beyond the mere right to purchase Celladon Products from Celladon or its Affiliates.

1.33 “Major Market” shall mean any of the following: (a) the United States of America; (b) the European Union as a whole; (c) England, France, Germany, Italy or Spain, individually; or (d) Japan.

1.34 “NDA” shall mean a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq.) or Biologics License Application (as more fully defined in 21 C.F.R. 601.2 et seq.), as applicable, and all amendments and supplements to either of the foregoing filed with the FDA, or the equivalent application filed with any equivalent agency or governmental authority outside the United States of America (including any supra-national agency such as in the European Union), including all documents, data, and other information concerning a pharmaceutical product which are necessary for gaining Regulatory Approval to market and sell such pharmaceutical product.

1.35 “Net Sales” shall mean the gross amounts invoiced or otherwise charged by Celladon, its Affiliates or Licensees for the sale or transfer of Celladon Products (excluding sales or transfers of Celladon Products to Affiliates or Licensees of the selling party for resale of such Celladon Products in transactions subject to sales royalties hereunder), less the following items, as allocable to such sale or transfer of such Celladon Products (if not previously deducted in calculating the amount invoiced): (i) reasonable and customary trade, quantity and cash discounts and rebates and retroactive price reductions or allowances actually allowed or granted; (ii) credits or allowances actually granted upon claims, rejections or returns of such sales of Celladon Products, including recalls; (iii) taxes, duties and other governmental charges imposed on the production, sale, delivery, use or importation of Celladon Products (including, without limitation, sales, use, excise or value added taxes, but excluding income taxes) that are included in the invoiced amount and paid by the purchasing party; (iv) government-mandated and other reasonably and customary rebates (such as those in respect of any state or federal Medicare, Medicaid or similar programs) and charge-backs, including those granted to managed care entities, in all such cases that effectively reduce the net selling price of such Celladon Product; (v) the actual amount of write-offs for bad debt directly relating to sales of Celladon Products, determined in accordance with U.S. generally accepted accounting practices, consistently applied, not to exceed 4.0% of gross amounts invoiced or charged; and (vi) transportation charges relating to such Products, including handling charges and insurance premiums relating thereto to the extent included in the invoiced amount and paid by the purchasing party.

In the event of (a) any sales or transfers of Celladon Products that are not at arm’s length, or (b) any sales or transfers of Celladon Products that are made in conjunction with sales of other products or services, with or without a separate price for such Celladon Product (in either case, a “Non-Arm’s-Length Transactions” ); then, for purposes of calculating royalties due hereunder, the Net Sales applicable to Celladon Products sold or transferred in such Non-Arm’s-Length Transaction shall be determined by multiplying (x) the number of units of Celladon Product sold or transferred in such Non-Arm’s-Length Transaction by (y) the average Net Sales per unit of such Celladon Product for all sales of such Celladon Product (excluding Non-Arm’s-Length

 

Transactions) made during the last full quarter prior to such transaction or during the current quarter if such Product was not commercially available throughout the last full quarter.

1.36 “New AAV Technology” shall mean:

(a) all (i)  [*] and (ii) Patents owned or Controlled by Celladon and/or its Affiliate and/or a Sublicensee during the Term that claim or cover any [*] , but excluding any claims contained within any such Patent that do not claim or cover any [*] ; and

(b) all [*] by Celladon and/or its Affiliate and/or a Sublicensee during the Term that [*] Information directed to any AAV Vector (or the manufacture or use thereof) invented or generated by or for ( e.g. , through a Celladon Designee or other contractor) Celladon and/or its Affiliate and/or a Sublicensee upon or after consummation of a Sale Transaction as a result of [*] ; but excluding [*] such Information ( “Post-Acquisition New AAV [*] ” ).

For the avoidance of doubt and without limiting the foregoing, New AAV Technology shall include (i) AAV-Vector-related Information [*] by Celladon and/or its Affiliate and/or a Sublicensee during the Term and generated or invented pursuant to any First Amendment Arrangement (whether before or after the Effective Date and whether before or after a Sale Transaction) and (ii)  [*] by Celladon and/or its Affiliate and/or a Sublicensee during the Term that [*] the Information described in the preceding clause (i); in each case, to the extent such rights and licenses are granted, licensed or otherwise provided to TGC under the terms and conditions of the First Amendment (as if such First Amendment survived the execution of this Agreement after the Effective Date), and the applicable terms and conditions of such First Amendment are hereby incorporated by reference for such purpose (but in any event excluding any Information or [*] that, by the terms and conditions of the First Amendment, are owned solely by TGC).

1.37 “[*] Agreement” shall mean the [*] License Agreement [*] by and between Targeted Genetics Corporation and the [*] as amended.

1.38 “Other License Transaction” shall mean the grant by Celladon or its Affiliate of a license to develop or commercialize Celladon Products; but excluding, in any event, (a) any Partnering Transaction, and (b) any fee-for-service agreement under which such Third Party’s license is limited to the conduct of contract development or manufacturing services by such Third Party on behalf of Celladon or its Affiliate (to the extent such agreement is limited to such a fee-for-service arrangement). If an agreement for an Other License Transaction is executed after consummation of a Sale Transaction, Section 3.3(b) shall not apply thereto in accordance with such Section 3.3(b).

1.39 “Partnering Consideration” shall mean all consideration (including but not limited to up-front license fees, license maintenance fees, and milestone payments) paid by a Licensee to Celladon or its Affiliates, in each case, in connection with a Partnering Transaction or Other License Transaction (with any of the foregoing consideration received by Celladon or its Affiliate other than in the form of cash to be valued at its fair market value as of the date of receipt). For purposes of clarification, and notwithstanding the preceding sentence, “Partnering Consideration” shall in any event exclude:

 

(a) up to [*] for any milestone payment paid or payable by a Licensee to Celladon or its Affiliates upon or with respect to initiation of a Phase 3 Clinical Trial of a Celladon Product (with any excess above [*] to be included in Partnering Consideration);

(b) royalties paid or payable to Celladon or its Affiliate by a Licensee based on such Licensee’s and its sublicensees’ sales of Celladon Products;

(c) any funds paid to reimburse Celladon for the cost of research and/or development by Celladon or its Affiliates (to the extent such funds do not exceed Celladon’s actual fully-burdened cost of performing such research and/or development);

(d) payments for equity or debt securities of Celladon or its Affiliates (except to the extent such payments exceed the fair market value of such securities upon date of receipt); and

(e) payments for the provision of goods (other than Celladon Products) and/or services by Celladon or its Affiliates to a Licensee to compensate Celladon or its Affiliates for the actual fully-burdened cost of such goods and/or services (to the extent such payments do not exceed such actual cost).

1.40 “Partnering Transaction” shall mean the execution by Celladon or its Affiliate and a Third Party of a definitive agreement pursuant to which Celladon or its Affiliate grants such Third Party: (a) an exclusive or co-exclusive rights to market and sell such Celladon Product in one or more Major Markets; and/or (b) other significant rights to market and sell such Celladon Product in one or more Major Markets (beyond the mere right to purchase Celladon Products from Celladon or its Affiliates), coupled with substantive rights and obligations to develop and seek Regulatory Approval of such Celladon Product. If any such agreement is executed after consummation of a Sale Transaction, Section 3.3(b) shall not apply thereto in accordance with such Section 3.3(b).

1.41 “Patents” shall mean (a) United States patents, re-examinations, reissues, renewals, extensions and term restorations, and foreign counterparts thereof, and (b) pending applications for United States patents, including, without limitation, provisional applications, continuations, continuations-in-part, divisional and substitute applications, including, without limitation, inventors’ certificates, and foreign counterparts thereof.

1.42 “Phase 3 Clinical Trial” shall mean a human clinical trial that would satisfy the requirements for a Phase 3 study as defined in 21 C.F.R. 312.21(c) (or its successor regulation or any equivalent regulation with respect to jurisdictions outside the United States, excluding, for the avoidance of doubt, Celladon’s ongoing phase I/II “CUPID” clinical trial for MYDICAR ^® (AAV1/SERCA2a) in Europe, even if the results thereof would support Regulatory Approval of MYDICAR ^® (AAV1/SERCA2a) in Europe).

1.43 “Pre-Acquisition New AAV Know-How” shall mean all Information directed to any AAV Vector (or the manufacture or use thereof), which Information:

(a) was invented or generated by or for ( e.g. , through a Celladon designee or other contractor) Celladon and/or its Affiliate (and, with respect to such Affiliate, only if as a result of such Affiliate or its contractor [*] ) during the term of the Collaboration Agreement, or is

 

invented or generated by or for Celladon and/or an Affiliate (and, with respect to such Affiliate, only if as a result of such Affiliate or its contractor [*] ) during the Term and prior to consummation of a Sale Transaction, but excluding any Patents with respect to any of the foregoing; or

(b) is invented or generated by or for a Sublicensee, either solely or jointly with Celladon and/or its Affiliate, as a result of [*] , during the Term and prior to consummation of a Sale Transaction, but excluding any Patents with respect to any of the foregoing.

1.44 “Product Family” shall mean, with respect to a particular Celladon Product containing a particular Composition, collectively, (a) such Celladon Product; and (b) all other Celladon Products that (i) contain the same Composition as such Celladon Product or (ii) are developed, or have received Regulatory Approval, for the same indication as such Celladon Product.

1.45 “Regulatory Approval” shall mean any and all approvals (including price and reimbursement approvals, if required), 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 Celladon Product in such jurisdiction.

1.46 “Released Materials” shall mean the [*] Material, the [*] Materials and the Additional Materials.

1.47 “Restricted Information” shall have the meaning provided in Section 2.2(f).

1.48 “Royalty Term” shall mean, in the case of any Celladon Product, in any country, the period of time commencing on the First Commercial Sale of such Celladon Product in such country and ending upon the later of (a)  [*] after the date of First Commercial Sale of such Celladon Product in such country, and (b) the expiration of the last to expire of the [*] containing a Valid Claim claiming or covering the Celladon Product (or the manufacture, use or sale of such Celladon Product) in such country.

1.49 “Sale Consideration” shall mean the total amount of cash and the fair market value (on the date of payment) of all other property paid by a Third Party to Celladon, its Affiliate(s), and its and their respective shareholders as consideration for a Sale Transaction, including amounts paid in respect of convertible securities, warrants, stock appreciation rights, options or similar rights, whether or not vested (but in each case net of applicable exercise prices), plus the amount of all indebtedness for borrowed money or capital lease obligations assumed or paid by the Third Party purchaser in connection with the Sale Transaction; in each case, net of all cash and cash equivalents of Celladon at the time of such Sale Transaction (provided that the amount deducted for such cash and cash equivalents shall not [*] Sale Consideration as calculated before any such deduction) and net of all out-of-pocket transaction fees paid to financial advisers and attorneys directly in connection with such Sale Transaction (provided that the amount deducted for such fees [*] Sale Consideration as calculated before any such deduction). If any portion of the foregoing amounts is paid into escrow, such portion shall be considered “Sale Consideration” only if and at such time (if ever) as such escrowed amounts are released to Celladon, its Affiliate(s) and/or its shareholders, and any escrowed amounts that are paid to or retained by the Third Party acquiror shall not be considered “Sale Consideration” for purposes of this Agreement.

 

1.50 “Sale Transaction” shall mean:

(a) any transaction or series of related transactions resulting in a consolidation or merger of Celladon with or into any other corporation or other entity or person, or any other corporate reorganization, in which the shareholders of Celladon immediately prior to such consolidation, merger or reorganization, own less than 50% of Celladon’s voting power immediately after such consolidation, merger or reorganization, or any transaction or series of related transactions in which in excess of 50% of Celladon’s voting power is transferred, but excluding (x) any transaction effected exclusively to change the domicile of Celladon, (y) any transaction or series of transactions effected solely for bona fide equity financing purposes in which cash is received by Celladon or indebtedness of Celladon is cancelled or converted or a combination thereof and (z) a consolidation with a wholly-owned subsidiary of Celladon; or

(b) the sale to a Third Party of all or substantially all of Celladon’s assets related to Celladon Products in a single transaction or series of related transactions.

Notwithstanding the foregoing, after the consummation of the first Sale Transaction (if any), no subsequent transaction falling within the scope of clause (a) or clause (b) of this Section 1.50 shall be considered a Sale Transaction for purposes of this Agreement.

1.51 “Sublicensee” shall mean a Licensee to whom Celladon sublicenses any of its rights under TGC Technology or TGC Licensed Technology as permitted by this Agreement.

1.52 “Technology Transfer” shall have the meaning provided in the Manufacturing Agreement.

1.53 “Term” shall have the meaning provided in Section 7.1.

1.54 “TGC Licensed Patents” shall mean all Patents that claim or cover any AAV Vector (or the manufacture or use thereof), excluding any claims contained within any such Patent that do not claim or cover an AAV Vector (or the manufacture or use thereof), which Patents TGC or any of its Affiliates (except as provided in Section 10.5(a)) Controls (but does not own) as of the Effective Date or during the Term, as a result of being licensed to TGC by a Third Party.

1.55 “TGC Licensed Technology” shall mean: (a) the TGC Licensed Patents; and (b) Information directed to any AAV Vector (or the manufacture or use thereof), which Information is Controlled (but not owned) by TGC or any of its Affiliates (except as provided in Section 10.5(a)) as of the Effective Date or during the Term, as a result of being licensed to TGC by a Third Party, but in any event excluding (i) any such Information invented or generated after the consummation of a Sale Transaction, (ii) any Patents with respect to the Information described in the preceding clause (b) (other than the TGC Licensed Patents), and (iii) any TGC Patents and other TGC Technology.

1.56 “TGC Patents” shall mean all Patents that claim or cover any AAV Vector (or the manufacture or use thereof), excluding any claims contained within any such Patent that do not claim or cover an AAV Vector (or the manufacture or use thereof), which Patents TGC or any of its Affiliates (except as provided in Section 10.5(a)) owns as of the Effective Date or during the

 

Term, including, without limitation, TGC’s ownership interest in any such Patents claiming Joint Inventions.

1.57 “TGC Product” shall have the meaning provided in Section 2.5(a).

1.58 “TGC Product Exclusion” shall have the meaning provided in Section 2.5(a).

1.59 “TGC Proprietary Product” shall mean a product which is or was identified through TGC’s internal research and development activities, or developed by, on behalf of, or in collaboration with TGC, and in which TGC has a proprietary interest ( e.g. , ownership or other control of intellectual property rights in such product, or the right to receive milestone payments associated with clinical development events or regulatory applications or approvals with respect to such product and/or milestone or royalty payments with respect to sales of such product), excluding Celladon Products, but including TGC Products for which TGC has a TGC Product Exclusion. For the avoidance of doubt, TGC’s performance of fee-for-service development or commercialization services on behalf, and for the benefit, of a Third Party shall not, in and of itself, be sufficient to qualify a product as a TGC Proprietary Product (to the extent such agreement is limited to such a fee-for-service arrangement).

1.60 “TGC Technology” shall mean: (a) the TGC Patents; and (b) Information directed to any AAV Vector (or the manufacture or use thereof), which Information is owned by TGC or any of its Affiliates (except as provided in Section 10.5(a)) as of the Effective Date or during the Term, including, without limitation, all such Information that is or was conceived or developed by TGC or any of its Affiliates, in performing its obligations under the Collaboration Agreement, the 2004 Manufacturing Agreement, the 2009 Letter or the Manufacturing Agreement, and all such Information that constitute Joint Inventions, but in any event excluding (i) any such Information invented or generated after the consummation of a Sale Transaction, (ii) any Patents with respect to the foregoing Information described in the preceding clause (b) (other than the TGC Patents), and (iii) any TGC Licensed Patents.

1.61 “Third Party” shall mean any entity other than Celladon or TGC or an Affiliate of Celladon or TGC.

1.62 “Third Party Agreement” shall mean any agreement between TGC and any Third Party under which TGC has a license with respect to any TGC Licensed Technology, regardless of whether or not such TGC Licensed Technology is actually being employed in the development, manufacture, use or sale of MYDICAR ^® (AAV1/SERCA2a) or any other Celladon Product as of the Effective Date, subject to Section 2.1(b).

1.63 “Third Party Payments” shall have the meaning provided in Section 1.16(d).

1.64 “Valid Claim” shall mean an unexpired claim of an issued patent within the Celladon Patents or TGC Patents or TGC Licensed Patents that has not been found to be unpatentable, invalid or unenforceable by a court or other authority of competent jurisdiction in the subject country, from which decision no appeal is taken or can be taken.

 

2.	L ICENSE .

2.1 License Grant to Celladon.

(a) License. Subject to the terms and conditions of this Agreement, TGC hereby grants to Celladon, during the Term, an exclusive [*] license, [*] under the TGC Technology and TGC Licensed Technology to [*] Celladon Products in the Field. Notwithstanding the exclusivity of the foregoing license, TGC shall retain the right to practice the TGC Technology and the TGC Licensed Technology solely in connection with the performance of its obligations under the Manufacturing Agreement. For the avoidance of doubt, nothing in this Section 2.1 is intended, nor shall it be construed, to create any obligation on the part of TGC and/or its Affiliate and/or any their licensors to disclose to Celladon any TGC Technology or TGC Licensed Technology; provided, however, that the foregoing shall not be construed to limit the disclosure obligations of TGC that are expressly set forth in this Agreement and in the Manufacturing Agreement.

(b) TGC Licensed Technology.

(i) Celladon acknowledges that the licenses granted under Section 2.1(a) are subject to and limited by the terms and conditions of the applicable Third Party Agreements (and the scope of rights licensed thereunder) pursuant to which the TGC Licensed Technology was licensed to TGC. TGC represents and warrants to Celladon that, except for the [*] Agreement, to TGC’s knowledge as of the Effective Date, Exhibit B attached hereto lists, as of the Effective Date, each and every Third Party Agreement licensing Patents to TGC that claim MYDICAR ^® (AAV1/SERCA2a), or the manufacture thereof, in its current form and as contemplated to be manufactured under the Manufacturing Agreement as of the Effective Date, including all Core Third Party Agreement Information for each such Third Party Agreement (or specific references to provisions of such Third Party Agreement containing such Core Third Party Agreement Information, provided that a true and complete copy of such Third Party Agreement, or of the relevant provisions of such Third Party Agreement, has been disclosed to Celladon as of the Effective Date).

(ii) [*] , to determine in good faith whether any other then-existing Third Party Agreements not initially listed on Exhibit B should be added to Exhibit B because (a) the [*] claims or covers MYDICAR ^® (AAV1/SERCA2a), or the manufacture thereof, in its then-current form and as then-currently manufactured, or (b) such [*] claims or covers any other Celladon Product that is then [*] by or on behalf of Celladon, or the manufacture thereof, and the parties shall amend Exhibit B hereto to include any such additional Third Party Agreement meeting the foregoing criteria as a Core Third Party Agreement hereunder. [*] Except for the Core Third Party Agreements, no Third Party Agreement, nor the rights licensed thereunder, shall be included within TGC Licensed Technology or TGC Licensed Patents for purposes of the operative terms and conditions of this Agreement (nor included in the license granted to Celladon hereunder), unless and until such Third Party Agreement becomes a Core Third Party Agreement listed on Exhibit B hereto [*] .

(iii) Celladon agrees to comply with the applicable terms and conditions of each Core Third Party Agreement that have been communicated to Celladon in writing (whether as part of Exhibit B , the provision by TGC to Celladon of copies of the applicable agreements or

 

portions thereof, or otherwise) and to take such actions as are reasonably required for TGC to comply with each Core Third Party Agreement with respect to Celladon’s (and its Affiliates’ and Licensees’) development and commercialization of Celladon Products and related exercise of its licensed rights hereunder, such as, for example and without limitation, providing such information and reports as are required for TGC to meet its reporting obligations under such Core Third Party Agreements with respect to Celladon’s (and its Affiliates’ and Licensees’) development and commercialization of Celladon Products. Celladon’s payment obligations with respect to Core Third Party Agreements shall be as set forth in Section 3.4.

(iv) With respect to the [*] Agreement, which is not a Core Third Party Agreement as of the Effective Date, TGC shall use Commercially Reasonable Efforts: [*] .

(c) Sublicensing. Celladon’s right to sublicense the license granted in Section 2.1(a) is limited solely to the grant of sublicenses in conjunction with [*] . For the avoidance of doubt, Celladon shall not have the right to grant a sublicense to a Third Party with respect to [*] . All sublicenses of rights under the TGC Technology and/or TGC Licensed Technology are subject to the terms and conditions of this Agreement. Celladon shall require all Sublicensees (including, without limitation, Sublicensees who are Affiliates) to comply with the applicable terms and conditions of this Agreement (and Celladon shall remain liable for any breach by such Sublicensee of any of the terms and conditions of this Agreement). Without limiting the generality of the foregoing, Celladon shall require each Sublicensee to grant to Celladon a license under New AAV Technology resulting from such Sublicensee’s practice of TGC Technology or TGC Licensed Technology, which license permits Celladon to grant TGC the sublicense contemplated by Section 2.6. Celladon shall provide to TGC a complete and accurate copy of all agreements granting any such sublicense hereunder within 30 days after such agreement is executed, provided that Celladon may redact from such copy any proprietary or confidential information that is not necessary for TGC to ascertain Celladon’s compliance with its obligations under this Agreement.

2.2 [*]Disclosure and Use of Released Materials.

(a) [*] for the sole purpose of exercising and fully exploiting the license granted to Celladon under Section 2.1, subject to Section 2.2(f) and the other terms and conditions of this Agreement. TGC acknowledges that Celladon intends to [*] promptly following the execution of this Agreement, [*] for the sole purpose of exercising and fully exploiting the license granted to Celladon under Section 2.1, subject to the terms and conditions of this Agreement (and Celladon and its Affiliates and Licensees shall not use such [*] Materials for any other purpose). TGC further agrees, promptly upon Celladon’s [*] request, to take all actions and execute such other instruments as may be necessary to effectuate the intent of this Section 2.2(a). Following such release of the [*] Materials, TGC shall no longer have any obligation to [*] .

(b) [*] which [*] Materials shall be used by Celladon for the sole purpose of exercising and fully exploiting the license granted to Celladon under Section 2.1, subject to Section 2.2(f) and the other terms and conditions of this Agreement. Immediately upon request by Celladon, TGC shall [*] which [*] Materials shall be used by Celladon for the sole purpose of exercising and fully exploiting the license granted to Celladon under Section 2.1, subject to the terms and conditions of this Agreement (and Celladon and its Affiliates and Licensees shall not use such [*] Materials for any other purpose). TGC further agrees, promptly upon Celladon’s [*]

 

request, to take all actions and execute such other instruments as may be necessary to effectuate the intent of this Section 2.2(b). Following such release of the [*] Materials, TGC shall no longer have any obligation to [*] . Celladon shall provide TGC reasonable access to such [*] Materials in reasonable quantities as necessary for TGC to address regulatory or clinical trial issues related to such materials that may arise during the Term.

(c) Additional Materials. Notwithstanding any provision of [*] to the contrary, TGC shall deliver to Celladon or its designee the [*] materials identified in Exhibit A to this Agreement (the “Additional Materials” ) within 30 days after the availability of same, subject to Section 2.2(f). The Additional Materials shall be used by Celladon for the sole purpose of exercising and fully exploiting the license granted to Celladon under Section 2.1, subject to the terms and conditions of this Agreement (and Celladon and its Affiliates and Licensees shall not use such Additional Materials for any other purpose). Celladon shall provide TGC reasonable access to such Additional Materials in reasonable quantities as necessary for TGC to address regulatory or clinical trial issues related to such materials that may arise during the Term.

(d) Disclosure and Use of Released Materials. The Released Materials shall constitute Confidential Information of TGC subject to Article 6. Without limiting Celladon’s obligations to keep the Released Materials confidential in accordance with Article 6, Celladon shall treat the Released Materials and any other Confidential Information of TGC (or its Affiliates or licensors) regarding the manufacture of AAV Vectors (collectively, the “TGC Manufacturing Information” ) as highly sensitive and confidential trade secrets of TGC and accordingly shall use commercially reasonable best efforts to preserve the confidentiality and prevent the unauthorized disclosure and publication thereof (using in any event no less care than Celladon would use to protect the confidentiality of its most sensitive and valuable trade secrets). Celladon shall not disclose any TGC Manufacturing Information to any Third Party without TGC’s prior written consent, except that Celladon shall have the right, in its discretion and without TGC’s consent, to disclose TGC Manufacturing Information to:

(i) Third Parties who are [*] , or who are [*] Celladon Products on behalf of Celladon, its Affiliates or Licensees in accordance with the license granted to Celladon under Section 2.1 and the other terms and conditions of this Agreement;

(ii) Third Parties with whom Celladon [*] of Celladon Products as described in the preceding clause (i); and

(iii) Third Parties [*] with respect to Celladon Products in connection with [*] ;

in all such cases, solely to the extent such disclosure is reasonably necessary for the [*] Celladon Products in accordance with this Agreement or reasonably necessary for the [*] for a contract with such Third Party for [*] . Any Third Party receiving a permitted disclosure of TGC Manufacturing Information as provided above shall be bound in writing to obligations of non-use and confidentiality with respect to such TGC Manufacturing Information to at least the same extent as provided for in this Agreement before any such disclosure is made to such Third Party. To the extent any TGC Manufacturing Information falls within any exception set forth in Section 6.2, the foregoing restrictions shall not apply with respect thereto.

 

(e) Retained Rights to Released Materials. TGC and its licensors retain ownership of, and all rights, title and interest in, to and under, the Released Materials, subject only to Celladon’s right to use such Released Materials as expressly provided for herein.

(f) Restrictions on Release and Disclosure. For purposes of this Section 2.2(f), “ Restricted Information ” shall mean any of the Released Materials or any other Information to be released or disclosed under the Technology Transfer or otherwise under the Manufacturing Agreement that, in each case, is subject to restrictions on release or disclosure (or use inconsistent with the uses contemplated hereunder) under any of TGC’s agreements with Third Parties, or for which TGC has no right to release or disclose (or authorize the use of as contemplated herein) under any such agreements with Third Parties. Notwithstanding anything to the contrary in the preceding provisions of this Section 2.2 or in the Manufacturing Agreement, but subject to the provisions of this Section 2.2(f), TGC shall have no obligation to release or disclose, or authorize the release or disclosure or use of [*] any Restricted Information, unless and until sufficient authorizations or agreements for such release and disclosure (and use, if applicable) from the applicable Third Party(ies) under TGC’s agreements with such Third Party(ies) are obtained. As of the Effective Date, a preliminary list of Restricted Information is set forth on Exhibit E hereto. TGC shall update such Exhibit E (to be attached hereto in place of the preliminary version) by February 28, 2009, which, once updated, will list all Restricted Information, along with the corresponding Third Party from which authorization is required, to the best of TGC’s knowledge.

(i) Promptly after February 28, 2009, TGC shall release and disclose [*] all Released Materials that TGC knows are not Restricted Information to the fullest extent practicable (and the implementation of Sections 2.2(a) through 2.2(c) shall commence only at such time).

(ii) TGC shall use Commercially Reasonable Efforts to identify any Restricted Information not initially included in Exhibit E as promptly as practicable after February 28, 2009 and shall keep Celladon regularly informed of the results of its efforts. For a reasonable period after the Effective Date (not to exceed five (5) months), the parties shall meet in person or by telephone or video conference from time to time, as reasonably requested by Celladon, to discuss any such Restricted Information and to consider the approval of an amendment of Exhibit E , which approval shall not be unreasonably withheld. Promptly following approval, the parties shall execute such amendment.

(iii) TGC shall use Commercially Reasonable Efforts to obtain, by [*] , 2009, all Third Party authorizations required for the release, disclosure and/or use of the Restricted Information identified on Exhibit E (in its then-current form) and to provide copies thereof to Celladon. Celladon shall reasonably cooperate with such efforts of TGC, including, if applicable, by entering into direct agreements with the applicable Third Party as reasonable and appropriate. If, despite its Commercially Reasonable Efforts, TGC is unable to obtain one or more of such Third Party authorizations by [*] , 2009, or if Exhibit E is subsequently amended to include any additional Restricted Information, the parties shall work together in good faith to obtain all required Third Party authorizations as promptly as practicable thereafter.

(iv) Promptly after receipt of any Third Party authorization required for the release, disclosure and/or use of any Restricted Information, TGC shall release or disclose, or authorize the release or disclosure or use of, the applicable Restricted Information.

 

2.3 Consequences of Certain Celladon Breaches. If Celladon materially breaches (i) any of its [*] under the Manufacturing Agreement and fails to cure such material breach within 15 days after TGC’s notice thereof to Celladon, or (ii) its obligations under [*] and fails to cure such material breach within 30 days after TGC’s notice thereof to Celladon (provided that TGC shall not unreasonably withhold its consent to the extension of the cure period under this subclause (ii) for up to an additional 60 days, or a total of 90 days from notice of breach); then, in either case, and without limiting any other rights or remedies TGC may have with respect to such breach:

(a) the license granted to Celladon pursuant to Section 2.1 shall be limited to the field of the treatment or prevention of congestive heart failure based on the modulation of the phospholamban/SERCA biological pathway utilizing one or more of the following: (i) phospholamban mutant gene (S16EPLN) to inhibit phospholamban-mediated events; (ii) sarco(endo)plasmic reticulum Ca(2+)-ATPase; (iii)  [*] and/or (iv)  [*] ;

(b) Celladon’s use of the Released Materials shall be limited to the fields described in Section 2.3(a) above;

(c) Celladon’s [*] rights under Sections 3.1(a) and 3.1(b) shall terminate and be of no further force or effect (except that the [*] with respect to any Product Family as to which Celladon exercised its [*] right prior to Celladon’s breach of [*] shall remain in full force and effect); and

(d) all other terms of this Agreement and the Manufacturing Agreement shall remain in effect.

2.4 Diligence. Except as otherwise expressly set forth in the Manufacturing Agreement, Celladon shall be solely responsible for the worldwide development, manufacture and commercialization of Celladon Products. Celladon agrees to use Commercially Reasonable Efforts to develop and obtain Regulatory Approval of Celladon Products in the Major Markets and in such other countries as Celladon deems appropriate and, following Regulatory Approval, to commercialize Celladon Products. Celladon shall provide updates to TGC of the progress of clinical development of Celladon Products, the filing of any IND or NDA with respect to a Celladon Product, and the Regulatory Approval of a Celladon Product in any jurisdiction, which updates shall be provided on a semiannual basis until the first Regulatory Approval of a Celladon Product and annually thereafter. Celladon and its Affiliates and Licensees shall comply with all applicable laws, rules and regulations in connection with the development, manufacture, marketing, promotion and sale of Celladon Products by Celladon or any of its Affiliates or Licensees.

2.5 Non-Competitive TGC Product Rights.

(a) Notwithstanding the exclusivity of Celladon’s license under Section 2.1, if TGC wishes to develop or commercialize any drug candidate or product that is within the scope of the definition of Celladon Product but that TGC in good faith believes would not pose a Competitive Threat to any Celladon Product being developed (at or beyond the stage at which pre-clinical, IND-enabling studies have been initiated) or commercialized by or on behalf of Celladon (including, without limitation, by or in collaboration with any Licensee(s)), then TGC may request in writing that Celladon exclude that specific TGC drug candidate or product (each, a “ TGC

 

Product” ) from the license granted by TGC to Celladon hereunder (each, a “TGC Product Exclusion” ), such that Celladon retains no rights under the TGC Technology or TGC Licensed Technology with respect to such TGC Product (which rights would revert back to TGC). Such written request shall identify the particular TGC Product and the likely indication(s) for which TGC expects to develop and commercialize such TGC Product. Each written request delivered by TGC to Celladon pursuant to this Section 2.5(a), including the information contained therein, shall be deemed Confidential Information of TGC.

(b) Within 30 days after receipt of TGC’s written request pursuant to Section 2.4(a), Celladon shall notify TGC in writing as to whether or not Celladon agrees that development and commercialization of such TGC Product would not pose a Competitive Threat to Celladon Products being developed (at or beyond the stage at which pre-clinical, IND-enabling studies have been initiated) or commercialized by or on behalf of Celladon (including, without limitation, by or in collaboration with any Licensee).

(i) If Celladon does so agree, then the applicable TGC Product shall thereupon be automatically excluded from the Celladon Product definition hereunder (and accordingly excluded from the license granted to Celladon by TGC hereunder, with such rights reverting back to TGC). The parties shall, without delay, execute a written document stating that the applicable TGC Product (as described in TGC’s initial notice to Celladon) is excluded from the definition of Celladon Product (and the license granted to Celladon hereunder) and setting forth the date such determination was made by the parties.

(ii) If Celladon does not so agree, then the parties shall promptly refer the matter to an independent Third Party consultant agreed upon by Celladon and TGC for resolution. Such consultant must have relevant expertise regarding commercialization of pharmaceutical products and be reasonably acceptable to both parties. For the avoidance of doubt, the sole authority of such consultant shall be to determine whether or not the applicable TGC Product poses a Competitive Threat to any Celladon Product being developed (at or beyond the stage at which pre-clinical, IND-enabling studies have been initiated) or commercialized by or on behalf of Celladon (including, without limitation, by or in collaboration with any Licensee(s)). Such consultant’s determination shall be final and binding upon the parties. The parties shall initially share equally the fees and expenses of such consultant, but the party against which such consultant rules shall reimburse the other party for the share of such fees and expenses initially borne by it promptly after the consultant renders its decision. If the consultant rules in TGC’s favor, then the applicable TGC Product shall thereupon be automatically excluded from the Celladon Product definition hereunder (and accordingly excluded from the license granted to Celladon by TGC hereunder, with such rights reverting back to TGC). The parties shall, without delay, execute a written document stating that the applicable TGC Product (as described in TGC’s initial notice to Celladon) is excluded from the definition of Celladon Product (and the license granted to