Back to top

LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: Bio-Management, Inc | CELL-MATRIX, INC | Micromet AG | MICROMET, INC | PARAMOUNT BIOSCIENCES, LLC | TRACON PHARMACEUTICALS, INC You are currently viewing:
This License Agreement involves

Bio-Management, Inc | CELL-MATRIX, INC | Micromet AG | MICROMET, INC | PARAMOUNT BIOSCIENCES, LLC | TRACON PHARMACEUTICALS, INC

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: LICENSE AGREEMENT
Governing Law: New York     Date: 5/10/2007
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AGREEMENT, Parties: bio-management  inc , cell-matrix  inc , micromet ag , micromet  inc , paramount biosciences  llc , tracon pharmaceuticals  inc
50 of the Top 250 law firms use our Products every day
 

Exhibit 10.1

***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and 240.24b-2

LICENSE AGREEMENT

     THIS LICENSE AGREEMENT (this “ Agreement ”) dated as of March 14, 2007 (the “ Effective Date ”) is entered into by and between CELL-MATRIX, INC., a Nevada corporation (“ Cell-Matrix ”), having a place of business at 2110 Rutherford Road, Carlsbad, California 92008, and TRACON PHARMACEUTICALS, INC., a Delaware corporation (“ Tracon ”), having a place of business at 4510 Executive Drive, Suite 330, San Diego, California 92121.

RECITALS

     WHEREAS, Cell-Matrix owns or has rights in the Cell-Matrix Patent Rights and the Technology (as each is defined below).

     WHEREAS, Cell-Matrix, formerly known as Bio-Management, Inc., obtained certain exclusive license patent rights pursuant to that certain License Agreement by and between Cell-Matrix and the University of Southern California (“ USC ”) effective as of September 14, 1999 (as amended from time to time, the “ USC Agreement ”).

     WHEREAS, Cell-Matrix obtained ownership to certain rights in and to modified antibodies pursuant to that certain Amended and Restated Collaboration Agreement by and between Cell-Matrix and Applied Molecular Evolution (“ AME ”) dated as of October 15, 2004 (as amended from time to time, the “ AME Agreement ”).

     WHEREAS, Cell-Matrix has obtained certain rights to negotiate and receive a commercial license grant (with the right to grant sublicenses) to certain production systems pursuant to that certain Research Evaluation Agreement between Micromet AG (an Affiliate of Cell-Matrix, Inc.) and [***] made on [***] (as amended from time to time, the “ [***] Agreement ”).

     WHEREAS, Tracon desires to obtain an exclusive license to the foregoing rights on the terms and conditions set forth below.

     NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the parties hereby agree as follows:

     1.  DEFINITIONS

     For purposes of this Agreement, the terms defined in this Section 1 shall have the respective meanings set forth below:

          1.1 “ Affiliate ” shall mean, with respect to any Person, any other Person which directly or indirectly controls, is controlled by, or is under common control with, such Person. A Person shall be regarded as in control of another Person if it owns, or directly or indirectly controls, at least fifty percent (50%) of the voting stock or other ownership interest of the other

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 


 

Person, or if it directly or indirectly possesses the power to direct or cause the direction of the management and policies of the other Person by any means whatsoever.

          1.2 “ AME ” shall have the meaning set forth in the Recitals to this Agreement.

          1.3 “ AME Agreement ” shall have the meaning set forth in the Recitals to this Agreement.

          1.4 “ BLA ” shall mean a Biologics License Application, Product License Application, New Drug Application, or Abbreviated New Drug Application submitted to the FDA, a Marketing Approval Application filed with the EMEA, and any corresponding applications in countries or territories other than the foregoing submitted to the relevant Competent Authority, in each case for marketing approval of a Product.

          1.5 “ Cell-Matrix In-Licenses ” shall mean the AME Agreement, [***] Agreement, the [***] License Agreement, and USC Agreement.

          1.6 “ Cell-Matrix Patent Rights ” shall mean (a) the patents and patent applications listed on Exhibit A hereto, (b) all patents and patent applications in any country of the world that claim or cover the Technology or its use, in each case in which Cell-Matrix has an ownership or (sub)licensable interest as of the Effective Date, but excluding the USC Patent Rights and the [***] Patent Rights, (c) all patents and patent applications in any country of the world to the extent specifically disclosing or claiming D93 [***], in each case in which Cell-Matrix has an ownership or (sub)licensable interest during the term of this Agreement, but excluding the USC Patent Rights and the [***] Patent Rights, (d) all divisions, continuations, and continuations-in-part, that claim priority to, or common priority with, the patent applications listed in clauses (a) — (c) above or the patent applications that resulted in the patents described in clauses (a) — (c) above (but, in the case of continuations-in-part, only to the extent that such continuations-in-part disclose or claim D93 or, provided that Tracon has exercised its option pursuant to Section 3.2, [***]), and (e) all patents that have issued or in the future issue from any of the foregoing patent applications, including utility, model and design patents and certificates of invention, together with any reissues, renewals, extensions or additions thereto.

          1.7 “ Clinical Plan ” shall have the meaning set forth in Section 3.9.

          1.8 “ Competent Authority(ies) ” shall mean, collectively, (a) the governmental entities in each country or supranational organization that is responsible for the regulation of any Product intended for use in the Field (including the FDA, the EMEA and the MHLW), or (b) any other applicable regulatory or administrative agency in any country or supranational organization that is comparable to, or a counterpart of, the foregoing.

          1.9 “ Confidentiality Agreement ” shall mean that certain Confidentiality Agreement made and entered into by Cell-Matrix and Paramount as of July 13, 2006.

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-2-


 

          1.10 “ D93 ” shall mean the humanized IgG1 antibody directed against denatured collagen with the variable domain amino sequence listed in Exhibit B , together with any derivatives, fragment or modifications of such antibody.

          1.11 “ D93 Product ” shall mean a Product comprising D93.

          1.12 “ Development Milestone ” shall have the meaning set forth in Section 8.3.

          1.13 “ EMEA ” shall mean the European Medicines Agency, or the successor thereto.

          1.14 “ FDA ” shall mean the Food and Drug Administration of the United States, or the successor thereto.

          1.15 “ Field ” shall mean the prevention, treatment, diagnosis, detection, monitoring, prognosis or predisposition testing for any disease, state or condition in humans or other animals.

          1.16 “ First Commercial Sale ” shall mean, with respect to any Product, the first sale of such Product after all applicable marketing and pricing approvals (if any) have been granted by the applicable Competent Authority of such country.

          1.17 “ [***] ” shall mean the [***] directed [***] with the [***] listed in Exhibit C , together with any [***] of such [***].

          1.18 “ [***] Product ” shall mean a Product comprising [***].

          1.19 “ Indication ” shall mean any condition or discrete disease pattern in the Field for which a BLA, supplemental BLA, or similar regulatory filing may be filed.

          1.20 “ JSC ” shall have the meaning set forth in Section 3.10.

          1.21 “ Knowledge ” shall mean the [***] (including, the [***] and [***]) of Cell-Matrix, Micromet, Inc. or any of their respective Affiliates and employees of Cell-Matrix, Micromet, Inc. or their respective Affiliates with [***] regarding the [***] and [***] regarding the [***].

          1.22 “ Licensed IP Rights ” shall mean, collectively, the Licensed Patent Rights and the Licensed Know-How Rights.

          1.23 “ Licensed Know-How Rights ” shall mean all trade secret and other know-how rights in which Cell-Matrix has an ownership interest or has a transferable interest, in and to all data, information, compositions and other technology (including, but not limited to, formulae, procedures, protocols, techniques and results of experimentation and testing) which are necessary or useful for Tracon to make, use, develop, sell or seek regulatory approval to market a

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-3-


 

Product, or to practice any method or process relating to a Product, and that (a) is at any time claimed or disclosed in any issued patent or pending patent application within the Cell-Matrix Patent Rights, or (b) exists as of the Effective Date or during the term of this Agreement to the extent specifically applicable to D93 [***] or is generated by Cell-Matrix or its Affiliates in the course of performing activities under this Agreement.

          1.24 “ Licensed Patent Rights ” shall mean (a) the Cell-Matrix Patent Rights, (b) the USC Patent Rights, and (c) if Cell-Matrix has obtained a commercial license grant from [***] under the [***] Agreement pursuant to Section 3.7, the [***] Patent Rights.

          1.25 “ [***] ” shall have the meaning set forth in the Recitals to this Agreement.

          1.26 “ [***] Agreement ” shall have the meaning set forth in the Recitals to this Agreement.

          1.27 “ [***] Know-How Rights ” shall mean all know-how for which Cell-Matrix obtains a sublicensable right under the [***] License Agreement.

          1.28 “ [***] License Agreement ” shall have the meaning as defined in Section 3.7.

          1.29 “ [***] Patent Rights ” shall mean all patents and patent applications for which Cell-Matrix obtains a sublicensable right under the [***] License Agreement.

          1.30 “ MHLW ” shall mean the Ministry of Health, Labour and Welfare of Japan, or the successor thereto.

          1.31 “ Net Sales ” shall mean, with respect to any Product, the gross sales price of such Product invoiced by Tracon, or any of its Affiliates or sublicensees to customers who are not a sublicensee (or are a sublicensee but are the end users of such Product) less, to the extent actually paid or accrued by Tracon, or any of its Affiliates or sublicensees (as applicable), (a) credits, allowances, discounts and rebates to, and chargebacks from the account of, such customers for nonconforming, damaged, out-dated and returned Product; (b) freight and insurance costs incurred by Tracon, or any of its Affiliates or sublicensees (as applicable) in transporting such Product to such customers to the extent separately invoiced; (c) cash, quantity and trade discounts, rebates and other price reductions for such Product given to such customers under price reduction programs; (d) sales, use, value-added and other direct taxes incurred on the sale of such Product to such customers; (e) customs duties, tariffs, surcharges and other governmental charges incurred in exporting or importing such Product to such customers; and (g) an allowance for uncollectible or bad debts taken with respect to such Product, in each case as determined in accordance with generally accepted accounting principles.

          1.32 “ Onset ” shall mean the first dosing of the first patient in the applicable clinical trial.

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-4-


 

          1.33 “ Paramount ” shall mean Paramount BioSciences LLC, a New York limited liability company.

          1.34 “ Person ” shall mean an individual, corporation, partnership, limited liability company, trust, business trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other form of entity not specifically listed herein.

          1.35 “ Phase I Clinical Trial ” shall mean a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its non-U.S. equivalent.

          1.36 “ Phase IIa Clinical Trial ” shall mean a human clinical trial that is intended to evaluate the pharmacokinetics and safety of a Product for a particular indication or indications in human subjects with the disease or indication under study and establish the dose of a Product or that would otherwise satisfy the requirements of US 21 C.F.R. §312.21(b) or its non-U.S. equivalent.

          1.37 “ Phase IIb Clinical Trial ” shall mean a human clinical trial that is intended to initially evaluate the efficacy of a Product for a particular indication or indications in human subjects with the disease or indication under study or that would otherwise satisfy the requirements of US 21 C.F.R. §312.21(b) or its non-U.S. equivalent.

          1.38 “ Phase III Clinical Trial ” shall mean a human clinical trial in any country the results of which could be used to establish safety and efficacy of a Product as a basis for a BLA or label expansion of a pharmaceutical product or that would otherwise satisfy the requirements of 21 C.F.R. 312.21(c), or its non-US equivalent.

          1.39 “ Pivotal Trial ” shall mean a Phase IIb Clinical Trial or Phase III Clinical Trial in any country the results of which could be used to establish safety and efficacy of a Product as a basis for a BLA or label expansion of a pharmaceutical product.

          1.40 “ Product(s) ” shall mean any product comprising D93[***] [***].

          1.41 “ Registration(s) ” shall mean any and all permits, licenses, authorizations, registrations or regulatory approvals (including BLAs) required and/or granted by any Competent Authority as a prerequisite to the development, manufacturing, packaging, marketing and selling of any product.

          1.42 “ Royalty Term ” shall mean, with respect to each Product in each country, the period commencing on First Commercial Sale in such country and expiring on a country-by-country basis on the later of (a) the expiration of the last-to-expire Valid Claim that would be infringed but for the license granted by this Agreement, by the manufacture, use, offer for sale, sale or import of such Product in such country, or (b) [***]years following the First Commercial Sale of such Product in such country.

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-5-


 

          1.43 “ Sublicense Agreement ” shall mean any agreement under which Tracon grants a sublicense under the license set forth in Section 3.1.

          1.44 “ Sublicensing Revenues ” shall mean, with respect to any Product, the aggregate consideration received by Tracon or any of its Affiliates in connection with an agreement under which Tracon grants a sublicense under any of the rights granted to Tracon under this Agreement to a Third Party (including upfront fees, annual license fees and milestone payments), but excluding amounts received by Tracon or any of its Affiliates (i) as [***]under this Agreement or the under the Cell-Matrix In-Licenses, (ii) to [***] or [***]after the execution of such sublicense, [***], for such Product; (iii) [***] relating to such Product; or (iv) in consideration for the [***]in a transaction not made in connection with a Sublicense Agreement. In the case of any [***]as shall be mutually agreed by the parties.

          1.45 “ Successful Completion ” shall mean that the applicable Phase I Clinical Trial has shown a safe and tolerable dose and that the Product had a side effect profile that does not adversely affect the applicable Product’s eligibility to enter the next phase clinical trial or, if applicable, to be subject to a BLA.

          1.46 “ Technology ” shall mean (a) D93 [***], (b) any derivatives, fragment or modifications of any such antibody, and (c) nucleotide sequences that encode any of the foregoing.

          1.47 “ Territory ” shall mean all countries of the world.

          1.48 “ Third Party ” shall mean any Person other than Cell-Matrix or Tracon or any of their Affiliates.

          1.49 “ USC ” shall have the meaning set forth in the Recitals to this Agreement.

          1.50 “ USC Agreement ” shall have the meaning set forth in the Recitals to this Agreement.

          1.51 “ USC Patent Rights ” shall mean the “PATENT” and “PATENTS” as defined in the USC Agreement.

          1.52 “ Valid Claim ” shall mean (a) a claim of an issued and unexpired patent included within the Licensed Patent Rights, which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise, and (b) a claim included in a pending patent application included in the Licensed Patent Rights that is being actively prosecuted and that has not been canceled, withdrawn from consideration, finally determined to be unallowable by the applicable governmental authority (from which no appeal is or can be taken), or abandoned or disclaimed, provided that notwithstanding the foregoing clause (b), in the event that a pending claim in a pending patent application does not issue in an issued

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-6-


 

patent within [***]after the earliest date from which such patent application claims priority, such a pending claim shall not be a Valid Claim, unless and until such pending claim subsequently issues in an issued patent, in which case such claim shall be reinstated and be deemed to be a Valid Claim as of the date of issuance of such patent in accordance with clause (a) above.

     2.  REPRESENTATIONS AND WARRANTIES

          2.1 Mutual Representations and Warranties . Each party hereby represents and warrants to the other party, as of the Effective Date, as follows:

               2.1.1 Such party is a corporation duly organized, validly existing and in good standing under the laws of the state in which it is incorporated.

               2.1.2 Such party (a) has the corporate power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and (b) has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding obligation, enforceable against such party in accordance with its terms (except as limited by applicable bankruptcy, insolvency, reorganization, moratorium or other laws of general application affecting enforcement of creditors’ rights, or as limited by general principles of equity that restrict the availability of equitable remedies).

               2.1.3 All necessary consents, approvals and authorizations of all governmental authorities and other Persons required to be obtained by such party in connection with this Agreement have been obtained.

               2.1.4 The execution and delivery of this Agreement and the performance of such party’s obligations hereunder (a) do not conflict with or violate any requirement of applicable laws or regulations, and (b) do not conflict with, or constitute a default under, any contractual obligation of it.

          2.2 Cell-Matrix Representations and Warranties . Cell-Matrix, Micromet, Inc., and Micromet AG each hereby represent and warrant to Tracon that, to its Knowledge as of the Effective Date:

               2.2.1 Cell-Matrix (a) is the sole owner or exclusive licensee of the Licensed IP Rights, and except as Cell-Matrix has expressly informed Tracon in writing prior to the date of this Agreement, has not granted to any Third Party any license or other interest in the Licensed IP Rights, (b) is not aware of any Third Party patent, patent application or other intellectual property rights that would be infringed by making, using or selling Products, except as Cell-Matrix has informed Tracon in writing prior to the date of this Agreement, and (c) is not aware of any infringement or misappropriation by a Third Party of the Licensed IP Rights.

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-7-


 

               2.2.2 Cell-Matrix has provided Tracon with complete and correct copies of all Cell-Matrix In-Licenses, and there have been no modifications, amendments or restatements other than as provided to Tracon prior to the Effective Date. The Cell-Matrix In-Licenses are in full force and effect in accordance with their terms. After giving effect to this Agreement, there exist no breaches, defaults or events which would (with the giving of notice, the passage of time or both) give rise to a breach, default or other right to terminate or modify any Cell-Matrix In-License. Cell-Matrix has not transferred or granted, and Cell-Matrix shall not transfer or grant, to any Third Party any license or other interest in the Cell-Matrix In-Licenses that would conflict with the rights granted to Tracon under this Agreement. With respect to the AME Agreement, Cell-Matrix does not have any further obligation to AME with respect to, and the negotiation and execution of this Agreement shall not result in any right accruing to AME pursuant to Section 7.5 of the AME Agreement. Other than [***] Cell-Matrix has not filed any Registrations with any Competent Authority for the Product.

          2.3 Tracon Covenant . Tracon covenants and agrees that it shall not knowingly, nor shall it knowingly cause or permit any Affiliate or sublicensee to, use or practice the Licensed IP Rights outside of the scope of the licenses granted in this Agreement, and not to knowingly take any action or knowingly make any omission that would cause Cell-Matrix to default under any of the Cell-Matrix In-Licenses, or otherwise provide the other party under the applicable Cell-Matrix In-License the right to terminate such Cell-Matrix In-License.

          2.4 Limitation on Representations or Warranties . Notwithstanding anything to the contrary in this Agreement, a party shall not be in breach of any representation or warranty made pursuant to Section 2 to the extent such breach arises directly from any fact or circumstance actually known by the other party on or prior to the Effective Date.

          2.5 Disclaimer of Warranties . EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN SECTION 2 AND SECTION 4.2.1, TRACON AND CELL-MATRIX MAKE NO REPRESENTATIONS AND GRANT NO WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND TRACON AND CELL-MATRIX EACH SPECIFICALLY DISCLAIMS ANY OTHER REPRESENTATIONS AND WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS, STATUTORY OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.

     3.  LICENSE GRANT

          3.1 Licensed IP Rights . Cell-Matrix hereby grants to Tracon an exclusive license (with the right to grant sublicenses through multiple tiers) under the Licensed IP Rights to conduct research and to develop, make, have made, use, offer for sale, sell, import and otherwise commercialize Products in the Territory for use in the Field.

                    

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-8-


 

          3.2 [***] to [***] . Cell-Matrix hereby grants to Tracon an [***] to obtain an [***] (with the [***]) under the [***]. Tracon may [***] at any time during the term of this Agreement. Upon receipt of such notice by Cell-Matrix, [***], and the terms of this Agreement shall apply to such [***] in all respects. Promptly following the [***] and the [***], Cell-Matrix shall [***] for the [***]then in Cell-Matrix’s possession.

          3.3 Reservation of Rights . Except for the rights expressly provided herein, nothing contained in this Agreement shall be construed as granting or conveying (expressly, by implication, or otherwise) to Tracon any license or other rights under any of patent, know-how or other intellectual property rights of Cell-Matrix or its Affiliates.

          3.4 Sublicenses . Tracon shall, in each Sublicense Agreement, require the sublicensee to transfer to Cell-Matrix if this Agreement terminates and to Tracon if only such sublicense terminates (a) documents and materials described in, and to the extent associated with, Section 11.5 held, possessed or transferable by such sublicensee; and (b) all patents and know-how claiming inventions or discoveries relating to the Products conceived or reduced to practice in the course of developing or commercializing the Products pursuant to the Sublicense Agreement owned or sublicensable by such sublicensee (which shall be transferred either by assignment or by license with rights to further sublicense). Any Sublicense Agreement shall be consistent with the terms and conditions of this Agreement. Tracon shall (i) provide Cell-Matrix with a copy of each Sublicense Agreement; (ii) use commercially reasonable efforts to procure the performance by any sublicensee of the terms of each such Sublicense Agreement, and (iii) be responsible for any breach of this Agreement that is caused (directly or indirectly) by the performance (or failures to perform) of its sublicensee. The grant of any such sublicense shall not relieve Tracon of its obligations under this Agreement, except to the extent they are satisfactorily performed by an Affiliate or sublicensee. In the event that Tracon, after [***], then [***] shall be [***].

          3.5 USC Agreement . Tracon agrees to be bound by the terms and conditions of the USC Agreement applicable to “SUBLICENSEES” (as defined in the USC Agreement). If, prior the Effective Date, Cell-Matrix has not obtained written permission from USC to grant the sublicense under the USC Patent Rights as set forth in this Agreement, then promptly following the Effective Date Cell-Matrix shall obtain such written consent from USC. Cell-Matrix shall timely perform in full all obligations required to be performed by Cell-Matrix under the USC Agreement. Cell-Matrix promptly shall provide Tracon with copies of all notices and other deliveries received under the USC Agreement. Without the prior express written consent of Tracon, Cell-Matrix shall not (and shall take no action or make no omission to) modify or waive any provision of the USC Agreement that could impair the value of the license and rights under the USC Patent Rights that are granted to Tracon herein, or to terminate or have terminated the USC Agreement. Within [***] following the Effective Date, Cell-Matrix shall propose a written amendment to USC that amends the USC Agreement such that if the USC Agreement [***], USC shall [***] and thereafter Cell-Matrix shall use reasonable efforts to negotiate and enter into such amendment with USC.

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-9-


 

          3.6 AME Agreement . Cell-Matrix shall timely perform in full all obligations required to be performed by Cell-Matrix under the AME Agreement. Cell-Matrix promptly shall provide Tracon with copies of all notices and other deliveries received under the AME Agreement. Without the prior express written consent of Tracon, Cell-Matrix shall not (and shall take no action or make no omission to) modify or waive any provision of the AME Agreement that could impair the value of the license and rights under the Cell-Matrix Patent Rights that are granted to Tracon herein, or to terminate or have terminated the AME Agreement.

          3.7 [***] Agreement . Tracon acknowledges that as of the Effective Date, Micromet AG’s rights under the [***] Agreement are limited to a non-sublicensable research and evaluation license grant. Within [***] following the Effective Date, Micromet AG shall exercise its option to obtain a commercial license under the [***] Agreement and shall cause Cell-Matrix to use reasonable efforts to seek and obtain from [***] a definitive license agreement (the “ [***] License Agreement ”) including a commercial license grant (with the right to grant sublicenses) under and in accordance with the [***] Agreement, and after obtaining such license grants, the [***] Patent Rights and [***] Know-How Rights, as applicable, shall be included within the scope of the Licensed IP Rights. Following the execution of the [***] License Agreement, Cell-Matrix shall timely perform in full all obligations required to be performed by Cell-Matrix under the [***] License Agreement. Cell-Matrix promptly shall provide Tracon with copies of all notices and other deliveries received under the [***] License Agreement. Without the prior express written consent of Tracon, Cell-Matrix shall not (and shall take no action or make no omission to) modify or waive any provision of the [***] License Agreement that could impair the value of the license and rights under the [***] Patent Rights or [***] Know-How Rights, as applicable, that are granted to Tracon herein, or to terminate or have terminated the [***] License Agreement.

          3.8 Transfer of Know-How and Product Materials . Promptly following the Effective Date, Cell-Matrix shall transfer to Tracon all Licensed Know-How Rights that exist in written or electronic form together with copies of all data, information, reports, protocols, Registrations (including, without limitation, [***]), and communications with Competent Authorities in each case with respect to the D93 Product and in existence as of the Effective Date, or in the case of the [***], on the effective date of [***]. Notwithstanding the foregoing, Cell-Matrix shall timely file the required annual report to [***] for the current calendar year and transfer such IND promptly after the filing of such annual report. Cell-Matrix shall make its and its Affiliates’ employees and consultants reasonably available to Tracon (at no cost to Tracon) for consultation as reasonably necessary to provide an orderly transfer of the foregoing information.

          3.9 Clinical Plan . Following the Effective Date, Tracon shall prepare and provide to Cell-Matrix a clinical development plan that sets forth Tracon’s intended research, development, manufacturing and clinical activities for the purpose of obtaining marketing approval of the Products (the “ Clinical Plan ”). From time to time during the term of this Agreement, as Tracon makes any significant changes to its intended development and clinical

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-10-


 

activities, but not less than once per calendar year, Tracon shall provide to Cell-Matrix an updated Clinical Plan.

          3.10 Joint Steering Committee . The parties shall establish a joint steering committee with at least one (1) representative appointed by each party to review and discuss progress of activities under the Clinical Plan (the “ JSC ”). The JSC shall meet on a semi-annual basis at times and places to be mutually agreed upon in good faith. The purpose of the JSC shall be solely to oversee such activities, and any decisions of the JSC on matters regarding such activities shall not be binding on the parties unless approved by all members of the JSC. The JSC will not have any power to amend this Agreement and will have only such powers as are specifically delegated to it under this Agreement. If, with respect to a certain matter, there is not unanimity by all members of the JSC, then the Chief Executive Officers of each party shall meet and attempt to resolve the matter. If after meeting and attempting to resolve any such matter the Chief Executive Officers of the parties are unable to resolve the matter, then the [***] shall have the final decision making authority with respect to such matter. The JSC shall be disbanded upon the date that is [***] from the Effective Date. In addition, Cell-Matrix shall have the right to disband the JSC with respect to a Product upon [***] written notice at any time after the [***] of such Product [***].

          3.11 Technical Assistance . For a reasonable period following completion of the transfer pursuant to Section 3.8, Cell-Matrix shall provide such technical assistance to Tracon as Tracon reasonably requests regarding the Licensed IP Rights, D93 Products [***], or Technology. Tracon shall pay to Cell-Matrix its documented reasonable out-of-pocket costs in providing such technical assistance, and reimburse Cell-Matrix for time of personnel of Cell-Matrix or its Affiliates engaged in the performance of such technical assistance at a reasonable cost to be agreed by the parties.

          3.12 Registrations . Tracon shall file and shall own all Registrations for Products for use in the Field in each country in the Territory.

     4.  PRODUCT SUPPLY

          4.1 Delivery . Promptly following the Effective Date, Cell-Matrix shall sell and deliver to Tracon the following materials (collectively, the “ Materials ”):

          (a) [***] of clinical trial grade materials consisting of D93;

          (b) Master cell banks for D93; and

          (c) all associated toxicology and reference material for D93 in Cell-Matrix’s possession or control.

          4.2 Delivery; Acceptance and Rejection .

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-11-


 

               4.2.1 Cell-Matrix shall transfer ownership to the Materials to Tracon at the facility of [***] (“ [***] ”) and the parties shall execute such documents as necessary with [***] to evidence such transfer of ownership, with delivery of the Materials to be deemed made to Tracon upon such transfer. Cell-Matrix hereby represents and warrants to Tracon that the Materials shall conform to the applicable specifications set forth in Exhibit D (the “ Specifications ”) at the time of such delivery. Tracon shall be responsible for transferring the Materials to its Third Party storage facility and for all risk of the loss of the Materials, storing and handling the materials in accordance all applicable requirements to maintain the quality thereof, and all costs associated for storage of the Materials by [***] or other Third Party, provided that the parties shall share equally in the cost of shipping of and insurance for the Materials from the [***] facility to such Third Party. Tracon shall inspect the Materials upon transfer of ownership, and conduct such testing as it deems appropriate to confirm that the Materials conform to the Specifications. Any Materials not rejected in writing within [***] after the date of transfer shall be deemed accepted, except to the extent of any nonconformity with the Specifications not discoverable through reasonable testing and in existence on the date of delivery (a “ Latent Defect ”). If Tracon determines that any Materials do not conform to the Specifications, it shall promptly provide written notice thereof to Cell-Matrix within the [***] acceptance period or within [***] of any discovery of any Latent Defect. If Cell-Matrix does not agree with Tracon’s determination, the Materials shall be submitted for inspection and testing by a mutually agreed upon independent laboratory, which shall make a final determination binding upon the parties as to whether the Materials in question met the Specifications as of the date of delivery. The cost of such testing shall be borne by the party against which the independent laboratory rules in its determination.

               4.2.2 If Materials are determined to be not conforming to the Specifications in accordance with the procedures set forth in Section 4.2.1 above, Cell-Matrix shall in its discretion replace the non-conforming Materials or reduce the applicable payments due under Section 4.3 pro rata of the quantity of the applicable Materials found to be not conforming. Such replacement or reduction in payment shall be Tracon’s sole and exclusive remedy in connection with any failure of Cell-Matrix to deliver Materials that conform to Specifications or with regard to any warranty made pursuant to Section 4.2.1.

          4.3 Payment Schedule . Tracon shall pay to Cell-Matrix a total of [***] ($[***]) in the aggregate for the Materials identified in Section 4.1 above, consisting of (a) [***] ($[***]) for the Materials described in Section 4.1(a), (b) [***] ($[***]) for the Materials described in Section 4.1(b), and (c) [***] ($[***]) for the Materials described in Section 4.1(c). Tracon shall pay the aggregate amount in accordance with the following payment schedule:

          (i) [***] ($[***]) within [***] of the Effective Date of this Agreement;

          (ii) [***] ($[***]) within [***] following the Effective Date;

          (iii) [***] ($[***]) within [***] following the Effective Date;

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-12-


 

          (iv) [***] ($[***]) within [***] following the Effective Date;

          (v) [***] ($[***]) within [***] following the Effective Date;

          (vi) [***] ($[***]) within [***] following the Effective Date;

          (vii) [***] ($[***]) within [***] following the Effective Date; and

          (viii) [***] ($[***]) within [***] following the Effective Date.

     5.  FINANCIAL CONSIDERATIONS

          5.1 License Fees . In consideration of the licenses granted hereunder, Tracon shall make the following non-refundable, non-creditable one-time payments to Cell-Matrix as follows:

                    (a) within [***] following the Effective Date, Tracon shall pay to Cell-Matrix [***] ($[***]), [***] ($[***]) of which is to be paid by Cell-Matrix to AME pursuant to Section 4.1.5(d) of the AME Agreement;

                    (b) on the [***] anniversary of the Effective Date, Tracon shall pay to Cell-Matrix [***] ($[***]); and

                    (c) within [***] following the delivery of the [***] pursuant to Section 3.2, Tracon shall pay to Cell-Matrix [***] ($[***]) which is to be paid by Cell-Matrix to AME pursuant to [***] the AME Agreement.

          5.2 Royalties . During the applicable Royalty Term for a Product, subject to the terms and conditions of this Agreement, Tracon shall pay to Cell-Matrix royalties, with respect to each Product, equal to [***] percent ([***]%) of Net Sales of such Product by Tracon, its Affiliates, or its sublicensees. Only one royalty shall be owing for a Product regardless of how many Valid Claims cover such Product. Tracon will be solely responsible for any royalties or other payments due to any Third Party in order to exercise rights hereunder to make, have made, use, sell, offer for sale or import any Product (excluding any payments that may be due under the Cell-Matrix In-Licenses, which are addressed in Section 5.6 below).

          5.3 Combination Products . If a Combination Product (as defined below) is sold, then for the purpose of calculating royalties owed under this Agreement on sales of the Combination Product, Net Sales shall be calculated as follows: first, Tracon shall determine the actual Net Sales of such Combination Product (calculated using the above described deductions) and then such amount shall be multiplied by the fraction A/(A+B), where A is the weighted (by sales volume) average invoice price of the actual Product component of such Combination Product, and B is the weighted (by sales volume) average invoice price of the other active ingredient(s) of such Combination Product or proprietary delivery device. If the invoice price of either the applicable Product, the other active ingredient(s) of such Combination Product or the

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-13-


 

or proprietary delivery device cannot be determined, Net Sales of such Combination Product shall be (i) equitably determined by the parties, and (ii) if no agreement can be reached, submitted to binding arbitration by a single arbitrator under the AAA arbitration rules for Commercial Disputes. “ Combination Product ” means [***] a product consisting of a Product and one or more other active ingredients[***].

          5.4 Sublicensing Revenues . During the applicable Royalty Term for a Product, subject to the terms and conditions of this Agreement, Tracon shall pay to Cell-Matrix a share of Sublicensing Revenues as follows:

                    (a) With respect to each agreement entered into by Tracon, its Affiliate or sublicensee prior to [***] for a particular Product, Tracon shall pay to Cell-Matrix [***] percent ([***]%) of the applicable Sublicensing Revenues received by Tracon or any of its Affiliates as a result of such agreement;

                    (b) With respect to each agreement (other than those described in clause (a) above) entered into by Tracon, its Affiliate or sublicensee prior to [***] for a particular Product, Tracon shall pay to Cell-Matrix [***] percent ([***]%) of the applicable Sublicensing Revenues received by Tracon or any of its Affiliates as a result of such agreement;

                    (c) With respect to each agreement (other than those described in clauses (a) or (b) above) that Tracon, its Affiliate or sublicensee enters into prior to [***] for a particular Product, Tracon shall pay to Cell-Matrix [***] percent ([***]%) of the applicable Sublicensing Revenues received by Tracon or any of its Affiliates as a result of such agreement; and

                    (d) With respect to each agreement that Tracon enters into after [***] for a particular Product, Tracon shall pay to Cell-Matrix [***] percent ([***]%) of the applicable Sublicensing Revenues received by Tracon or any of its Affiliates as a result of such agreement.

          5.5 Milestones .

               5.5.1 Milestones due for any Product . Tracon shall pay to Cell-Matrix the following non-refundable, non-creditable one-time milestone payments within [***] following the first achievement of the applicable milestone event:

 

$[***] 

 

Successful Completion of the first Phase I Clinical Trial for a Product conducted by or for Tracon, its Affiliate or sublicensee;

 

 

 

 

 

$[***] 

 

Onset of the first Phase IIa Clinical Trial for a Product conducted by or for Tracon, its Affiliate or sublicensee;

 

 

 

 

 

$[***] 

 

Onset of the first Pivotal Trial for a Product conducted by or for Tracon, its Affiliate or sublicensee;

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

-14-


 

For the avoidance of doubt, each milestone shall be paid once irrespective of the number of times such milestone is achieved by one or more Products and the total aggregate milestones payable under Section 5.5.1 in the aggregate for all Products shall not exceed $[***].

If a milestone event described in Section 5.5.1 is achieved that is subsequent to a preceding milestone event with respect to which Tracon has not yet made the corresponding milestone payment, the preceding milestone event is deemed achieved, and the corresponding milestone payment is due and payable together with the payment of the milestone payment for the subsequent milestone event.

               5.5.2 BLA Acceptance and Approval Milestones due for D93 [***] . Tracon shall pay to Cell-Matrix the following non-refundable, non-creditable one-time milestone payments within [***] following [***] the first achievement of the applicable milestone event with a D93 Product, [***]:

 

$[***] 

 

upon acceptance for review by the FDA of the first BLA submitted by Tracon, its Affiliate or sublicensee for the first Indication for [***] the D93 Product [***];

 

 

 

 

 

$[***] 

 

upon acceptance for review by the EMEA of the first BLA submitted by Tracon, its Affiliate or sublicensee for the first Indication for [***] the D93 Product [***];

 

 

 

 

 

$[***] 

 

upon acceptance for review by the MHLW of the first BLA submitted by Tracon, its Affiliate or sublicensee for the first Indication for [***] the D93 Product [***];

 

 

 

 

 

$[***] 

 

upon acceptance for review by the FDA of the first BLA submitted by Tracon, its Affiliate or sublicensee for the second Indication for [***] the D93 Product [***];

 

 

 

 

 

$[***] 

 

upon acceptance for review by the EMEA of the first BLA submitted by Tracon, its Affiliate or sublicensee for the second Indication for [***] the D93 Product [***];

 

 

 

 

 

$[***] 

 

upon acceptance for review by the MHLW of the first BLA submitted by Tracon, its Affiliate or sublicensee for the second Indication for [***] the D93 Product [***];

 

 

 

 

 

$[***] 

 

upon acceptance for review by the FDA of the first BLA submitted by Tracon, its Affiliate or sublicensee for the third Indication for [***] the D93 Product [***];

 

 

 

 

***

 

Certain information on this page has been omitted and filed separately with the Commission. Confidential


 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more