EX-10.12 12 d269230dex1012.htm EX-10.12 CONFIDENTIAL TREATMENT REQUESTED EXCLUSIVE PATENT LICENSE AGREEMENT by and between MERCK, SHARP & DOHME CORPORATION and TARGENICS, Inc. CONFIDENTIAL TREATMENT REQUESTED EXCLUSIVE PATENT LICENSE AGREEMENT
Exhibit 10.12
CONFIDENTIAL TREATMENT REQUESTED
EXCLUSIVE PATENT LICENSE AGREEMENT
by and between
MERCK, SHARP & DOHME CORPORATION and
TARGENICS, Inc.
CONFIDENTIAL TREATMENT REQUESTED
EXCLUSIVE PATENT LICENSE AGREEMENT
THIS EXCLUSIVE PATENT LICENSE AGREEMENT (this “Agreement”), dated as of December 12, 2012 (the “Effective Date”), is by and between Merck, Sharp & Dohme Corporation, a corporation organized and existing under the laws of New Jersey (hereinafter referred to as “Merck”), and Targenics, Inc., a corporation organized and existing under the laws of Delaware (hereinafter referred to as “Licensee”). Merck and Licensee are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
WHEREAS, Licensee desires to develop and commercialize PEG-IL10; and
As used in this Agreement, the following capitalized terms, whether used in the singular or plural, shall have the respective meanings set forth below:
1.01 “Affiliate” shall mean any individual or entity directly or indirectly controlling, controlled by or under common control with a Party to this Agreement. For purposes of this Agreement, the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of an entity, or the right to receive fifty percent (50%) or more of the profits or earnings of an entity shall be deemed to constitute control. Such other relationship as in fact results in actual control over the management, business and affairs of an entity shall also be deemed to constitute control.
1.02 “Calendar Quarter” shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31, for so long as this Agreement is in effect.
1.03 “Calendar Year” shall mean each successive period of twelve (12) months commencing on January 1 and ending on December 31, for so long as this Agreement is in effect.
1.04 “Clinical Trial” shall mean a Phase I Clinical Trial, Phase II Clinical Trial, Phase III Clinical Trial, and/or Post-approval Clinical Trial.
1.05 “Combination Product” shall mean a Licensed Product which includes one or more active ingredients, other than Licensed Compound, in combination with Licensed Compound. All references to Licensed Product in this Agreement shall be deemed to include Combination Product.
1
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
1.06 “Commercialization” shall mean, with respect to Licensed Product, any and all activities directed to the marketing, promotion, distribution, offering for sale and selling such product, importing and exporting such product for sale, and interacting with Regulatory Authorities regarding the foregoing. Commercialization shall also include Commercialization Studies. “Commercialize” has a correlative meaning.
1.07 “Commercialization Studies” shall mean a study or data collection effort for the Licensed Product that is initiated in the Territory after receipt of Marketing Authorization for the Licensed Product and is principally intended to support the Commercialization of the Licensed Product in the Territory; provided, that such study or data collection effort is not principally to support or maintain a Marketing Authorization or obtain a label change or maintain a label.
1.08 “Compound Patent Rights” shall mean patents and patent applications that are listed on the attached Schedule A (as well as substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, certificates of invention, confirmations, re-examinations, extensions, supplementary protection certificates or the like, or the provisional applications of any such patents and patent applications; and foreign equivalents thereof) that, as of the Effective Date, are owned or controlled by Merck (and/or any of its Affiliates) having claims specifically covering the Licensed Compound or the Manufacture and/or use thereof.
1.09 “Development” or “Develop” shall mean all preclinical research and development activities and all clinical drug development activities, including, among other things: drug discovery, toxicology, formulation, statistical analysis and report writing, conducting clinical trials for the purpose of obtaining and maintaining Marketing Authorization (including without limitation, post-marketing studies), and regulatory affairs related to all of the foregoing. Development shall include all clinical studies (including Phase III-B) that are primarily intended to support or maintain a Marketing Authorization, maintain a label or obtain any label change, but shall exclude Commercialization Studies.
1.10 “Diligent Efforts” shall mean [***].
1.11 “Field” shall mean the use of the Licensed Compound or the Licensed Product to treat or prevent any disease, disorder or condition in humans only; except that it shall not include research, development, manufacture, import, marketing, distribution or sale of the Licensed Compound or Licensed Product for the acceleration or promotion of healing of wounds (including chronic wounds), the prevention or reduction of scarring, or the treatment or prevention of fibrotic disorders; at any body sites.
1.12 “First Commercial Sale” shall mean, with respect to a country in the Territory, the first shipment of commercial quantities to a Third Party, of a Licensed Product sold in such country to a Third Party on arm’s length terms, by Licensee, its Affiliate or sublicensee for use in the Field after the receipt of Marketing Authorization in such country. Sales for test marketing, sampling and promotional uses, Clinical Trial purposes or compassionate or similar use shall not be considered to constitute a First Commercial Sale.
2
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
1.13 “Good Clinical Practices” shall mean the then current Good Clinical Practices as such term is defined from time to time by the United States Food and Drug Administration (“FDA”) or other relevant governmental authority having jurisdiction over the Development, Manufacture or sale of Licensed Product in the Territory pursuant to its regulations, guidelines or otherwise.
1.14 “Good Laboratory Practices” shall mean the current good laboratory practice regulations of the FDA as described in the United States Code of Federal Regulations (“CFR”) or any comparable corresponding foreign regulations or their respective successor regulations.
1.15 “Good Manufacturing Practices” shall mean the then current Good Manufacturing Practices as such term is defined from time to time by the FDA or other relevant governmental authority having jurisdiction over the Development, Manufacture or sale of Licensed Product in the Territory pursuant to its regulations, guidelines or otherwise.
1.16 “IND” shall mean an investigational new drug application with respect to the Licensed Product filed with the FDA for beginning clinical trials in humans, or any comparable application filed with the Regulatory Authorities of a country other than the United States prior to beginning clinical trials in humans in that country, as well as all supplements or amendments filed with respect to such filings.
1.17 “Know-How” shall mean any and all proprietary information and materials (whether patentable or not) related to the Licensed Compound, Licensed Product, any Combination Product, formulation, product improvement and/or indication, or the Development, Manufacture or use of any of the foregoing, that are not in the public domain, including, without limitation, (a) ideas, discoveries, inventions, improvements, technology or trade secrets, (b) pharmaceutical, chemical and biological materials, products, components or compositions, (c) methods, procedures, formulas, processes, tests, assays, techniques, regulatory requirements and strategies, (d) biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, Manufacturing and quality control data and information related thereto, (e) technical and non-technical data and other information related to the foregoing, (f) drawings, plans, designs, diagrams, sketches, specifications or other documents containing or relating to such information or materials and (g) all applications, registrations, licenses, authorizations, approvals and correspondence relating to the Licensed Compound and/or Licensed Product submitted to Regulatory Authorities.
1.18 “Licensee” shall have the meaning given to such term in the preamble of this Agreement.
1.19 “Licensee Know-How” shall mean any and all Know-How developed by Licensee and/or any of its Affiliates or sublicensees after the Effective Date.
3
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
1.20 “Licensee Patent Rights” shall mean patents and patent applications (as well as substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, certificates of invention, confirmations, re-examinations, extensions, supplementary protection certificates or the like, or the provisional applications of any such patents and patent applications; and foreign equivalents thereof) that, as of the Effective Date, are owned or controlled by Licensee (and/or any of its Affiliates) having claims specifically covering the Licensed Compound or the Manufacture and/or use thereof.
1.21 “Licensed Compound” shall mean PEG-IL10.
1.22 “Licensed Product” shall mean any pharmaceutical composition, dosage form or preparation, including, without limitation, a Combination Product that contains as an active ingredient the Licensed Compound or any metabolite, prodrug, acid form, base form, ester, salt, stereoisomer, racemate, tautomer or polymorph of a Licensed Compound.
1.23 “Major European Country” shall mean any of France, Germany, Italy, Spain or the United Kingdom.
1.24 “Manufacture” shall mean all activities related to the manufacturing of a pharmaceutical product, or any ingredient thereof, including but not limited to test method development and stability testing, formulation, process development, manufacturing for use in non-clinical or clinical studies, manufacturing scale-up, manufacturing Licensed Compound or Licensed Product quality assurance/quality control development, quality control testing (including in-process release and stability testing), packaging, release of product or any component or ingredient thereof, quality assurance activities related to manufacturing and release of product, and regulatory activities related to all of the foregoing.
1.25 “Marketing Authorization” shall mean all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in any country (including without limitation all applicable Price Approvals even if not legally required to sell Licensed Product in a country).
1.26 “Merck Know-How” shall mean the Know-How owned or controlled by Merck and/or any of its Affiliates as of the Effective Date that was used by Merck or its Affiliates as of the Effective Date in the Development or Manufacture of Licensed Compound that is listed on Schedule B or is otherwise provided to Licensee by Merck under this Agreement.
1.27 “NDA” shall mean a New Drug Application, Biologics License Application, Worldwide Marketing Application, Marketing Application Authorization, filing pursuant to Section 510(k) of the Act, or similar application or submission for Marketing Authorization of a Product filed with a Regulatory Authority to obtain marketing approval for a biological, pharmaceutical or diagnostic product in that country or in that group of countries.
1.28 “Net Sales” shall mean the gross invoice price (not including value added taxes, sales taxes, or similar taxes) of Product sold by Licensee or its Related Parties to the first Third Party after deducting, if not previously deducted, from the amount invoiced or received:
[***].
4
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
Sales or other commercial dispositions of Licensed Products between or among Related Parties shall be excluded from the computation of Net Sales if such sales are not intended for end use. Licensed Products provided to Third Parties without charge, in connection with research and development, clinical trials, compassionate use, humanitarian and charitable donations or indigent programs for use as samples shall be excluded from the computation of Net Sales and no payments will be payable on such dispositions.
1.29 “PEGylated” shall mean attached to a polyethylene glycol molecule.
1.30 “PEG-IL10” shall mean PEGylated human interleukin-10 polypeptide but not un-PEGylated human interleukin-10 polypeptide.
1.31 “Price Approval” shall mean the approval or determination by a Regulatory Authority for the pricing or pricing reimbursement for a pharmaceutical product.
1.32 “Proprietary Information” shall mean, as applicable, Know-How and all other scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing, verbally or electronically, that is provided by one Party to the other Party in connection with this Agreement.
1.33 “Regulatory Authority” shall mean any United States federal, state, or local government, or any foreign government, or political subdivision thereof, or any multinational organization or authority or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body with responsibility for granting licenses or approvals, including Marketing Authorizations, necessary for the marketing and sale of the Licensed Product in any country.
1.34 “Related Party” shall mean each of Licensee, its Affiliates, and their respective sublicensees (which term does not include distributors), as applicable.
1.35 “Territory” shall mean the entire world.
1.36 “Third Party” shall mean an entity other than Merck and its Affiliates and Licensee and its Related Parties.
1.37 “Valid Claim” shall mean a claim of an issued and unexpired patent included within the Compound Patent Rights, that has not been revoked or held 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 that has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue or disclaimer.
5
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
Definition | Section | |
AAA | 13.02(a) | |
Agents | 9.01(b) | |
Agreement | Preamble | |
CFR | 1.14 | |
Change of Control | 14.01(c) | |
Development Plan | 3.02 | |
Development Report | 3.03 | |
Effective Date | Preamble | |
Excluded Claim | 13.02 | |
FDA | 1.13 | |
Force Majeure | 14.08 | |
Liability | 11.01 | |
LIBOR | 7.05(e) | |
Licensee Indemnified Party | 11.02 | |
Merck Indemnified Party | 11.01 | |
Sublicense Agreement | 2.04 | |
Term | 12.01 |
6
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
2.04 Section 365(n) of the Bankruptcy Code. All rights and licenses granted under or pursuant to any section of this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Bankruptcy Code. Each Party shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code or equivalent legislation in any other jurisdiction. Upon the bankruptcy of either Party, the other Party shall further be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property, and such, if not already in its possession, shall be promptly delivered to such other Party, unless the Party in bankruptcy elects to continue, and continues, to perform all of its obligations under this Agreement.
ARTICLE III – DEVELOPMENT AND COMMERCIALIZATION
7
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
4.01 Materials and Regulatory Filings Transfer.
(a) Following the Effective Date of this Agreement, but not before the payment of the consideration under Section 7.01 by Licensee to Merck, Merck shall transfer to Licensee, in a mutually agreed manner, the [***] reasonably within the possession and control of Merck and necessary for Licensee to make, use and sell the Licensed Product. Any obligation of Merck to transfer such tangible material to Licensee and to provide assistance and support with such materials will not extend beyond [***] days after the Effective Date and will only be to the extent possible by the expenditure of commercially reasonable efforts.
(b) Licensee or its Affiliates shall hold all Marketing Authorizations for Licensed Product in the Territory in the Field.
8
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
(c) Licensee shall oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, the FDA and other regulatory authorities in the Field in the Territory with respect to Licensed Product.
(d) Licensee shall be solely responsible for interfacing, corresponding and meeting with the FDA and other regulatory authorities throughout the Territory with respect to Licensed Product.
(e) Licensee shall provide to Merck a [***] that contains the status of Marketing Authorizations for the Licensed Product in the Territory.
(f) In the event that any Regulatory Authority (a) threatens or initiates any action to remove a Licensed Product from the market in any country in the Field in the Territory or (b) requires Licensee, its Affiliates, or its sublicensees to distribute a “Dear Doctor” letter or its equivalent regarding use of Licensed Product in the Field, Licensee shall notify Merck of such event within one (1) business day after Licensee becomes aware of the action, threat, or requirement (as applicable). Licensee shall consult with Merck prior to initiating a recall or withdrawal of Licensed Product in the U.S., Japan, or a Major European Country; provided, however, that the final decision as to whether to recall or withdraw a Licensed Product in the Territory shall be made by Licensee in its sole discretion. Licensee shall be responsible, at its sole expense, for conducting any recalls or taking such other necessary remedial action.
(g) [***].
ARTICLE VII – PAYMENTS; ROYALTIES AND REPORTS
9
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
Milestone | Payment | |||
[***] | [ | ***] |
Licensee shall promptly notify Merck in writing after the achievement of each such milestone event giving rise to a payment obligation under this Section and Licensee shall pay Merck the indicated amount no later than [***] days after the achievement of each milestone event giving rise to a payment obligation under this Section 7.02.
[***].
7.04 Reports; Payment of Royalty; Payment Exchange Rate and Currency Conversions.
(a) Royalties Paid Quarterly. Within [***] calendar days following the end of each Calendar Quarter, following the First Commercial Sale of a Licensed Product, Licensee shall furnish to Merck a written report for the Calendar Quarter showing the Net Sales of Licensed Product sold by Licensee, its Affiliates and its sublicensees in the Territory during such Calendar Quarter and the royalties payable under this Agreement for such Calendar Quarter. Such written report shall include the gross sales of Licensed Product on a country-by-country basis, an itemized calculation of any deductions taken from such gross sales to arrive at Net Sales for the applicable Calendar Quarter and the calculation of the amount of royalty payment due on such Net Sales. Simultaneously with the submission of the written report, Licensee shall pay to Merck, for the account of Licensee or the applicable Affiliate or sublicensee, as the case may be, a sum equal to the aggregate royalty due for such Calendar Quarter calculated in accordance with this Agreement.
10
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
7.05 Maintenance of Records; Audits.
11
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
8.02 All Inventions that are created during the Term of the Agreement jointly by employees, Affiliates, agents, independent contractors or consultants of Licensee and employees, Affiliates, agents, independent contractors or consultants of Merck that claim or cover the Licensed Product or Licensed Compound shall be owned jointly by Merck and Licensee (“Joint Patent Rights”). Merck hereby grants to Licensee an exclusive (even as to Merck and its Affiliates), license, in the Field in the Territory, with the right to grant sublicenses under the Joint Patent Rights to Develop, make, have made, use, import, export, Commercialize, sell, offer for sale, and market the Licensed Compound and the Licensed Product. Licensee agrees to prosecute and maintain in the Territory, through outside counsel, the Joint Patent Rights. Following the [***] milestone referred to in Section 7.02, however, at the request of Licensee, [***]. Licensee also agrees to manage, through outside counsel, any administrative challenge to the Joint Patent Rights including any interference, post-grant review, inter partes review, derivation proceeding, opposition, reexamination, reissue or similar administrative proceeding. Licensee may use outside counsel of its choice for matters in connection with the Joint Patent Rights.
12
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
13
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
(c) Recovery. Any recovery or damages derived from any suit brought under Section 8.04 (“Recovery”) shall be shared as follows: (i) the amount of such Recovery shall be used first to reimburse each of Merck and Licensee for its documented out-of-pocket legal expenses relating to the suit, and then (ii) any remaining amounts to be shared by the Parties as follows:
[***]
8.05 Infringement and Third Party Licenses.
(c) If Licensee obtains additional rights to Develop, make, have made, use, import, export, Commercialize, sell, offer for sale, and market subject matter relating to IL-10, and if Merck, alone, deems such rights to be sufficient and obtained in a manner not prejudicial to Merck’s rights under existing agreements, then Merck and Licensee will agree to execute an amendment to this Agreement to define Field, under Section 1.11 of this Agreement, to include acceleration or promotion of healing of wounds (including chronic wounds), the prevention or reduction of scarring, or the treatment or prevention of fibrotic disorders. In the event that Licensee obtains such rights, Licensee agrees to cooperate fully with Merck in providing sufficient evidence to Merck of such rights and the manner obtained.
14
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
ARTICLE IX – CONFIDENTIALITY AND PUBLICATION
(i) is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party’s written records;
(ii) is at the time of disclosure, or thereafter becomes, published or otherwise part of the public domain without breach of this Agreement by the receiving Party;
(iii) is subsequently disclosed to the receiving Party by a Third Party who has the right to make such disclosure, as documented by the receiving Party’s written records;
(iv) is independently developed by the receiving Party or its Affiliates and without the aid, use or application of any of the disclosing Party’s Proprietary Information, and such independent development can be documented by the receiving Party’s written records;
(v) is disclosed to any institutional review board of any entity conducting clinical trials with Licensed Product or to any governmental or other regulatory agencies in order to obtain patents or to gain approval to conduct clinical trials or to market Licensed Product, provided that such disclosure may be made only to the extent reasonably necessary to obtain such patents or authorizations; or
(vi) is required to be disclosed by law, regulation, rule, act or order of any governmental authority or agency to be disclosed, provided that notice is promptly delivered to the other Party in order to provide an opportunity to seek a protective order or other similar order with respect to such Proprietary Information and thereafter the receiving Party discloses to the requesting entity only the minimum information required to be disclosed in order to comply with the request, whether or not a protective order or other similar order is obtained by the other Party.
15
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
16
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
Third Party in connection with (i) a financing (or proposed financing) or an equity investment (or proposed investment) in such Party or its Affiliates, including to its shareholders and prospective shareholders, (ii) a merger, consolidation or similar transaction by such Party or its Affiliates, (iii) the sale of all or substantially all of the assets of such Party or its Affiliates, or (iv) in connection with a Securitization, provided that such Third Party executes a non-use and non-disclosure agreement and observes the same obligations of confidentiality as such Party owes under this Agreement with respect to Proprietary Information of the other Party; (c) to the United States Securities and Exchange Commission or any other securities exchange or governmental entity, including as required to make an initial or subsequent public offering, or (d) as otherwise required by law or regulation, provided that in the case of (c) and (d) the disclosing Party shall (x) if practicable, provide the other Party with reasonable advance notice of and an opportunity to comment on any such required disclosure, (y) if requested by such other Party, seek, or cooperate with such Party’s efforts to obtain, confidential treatment or a protective order with respect to any such disclosure to the extent available at such other Party’s expense, and (z) use good faith efforts to incorporate the comments of such other Party in any such disclosure or request for confidential treatment or protective order.
ARTICLE X – REPRESENTATIONS AND WARRANTIES
(a) it is a corporation duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation;
(b) the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action;
(c) it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder;
(d) the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions herein does not and will not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its corporate charter or other operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound;
(e) except for the governmental and Marketing Authorizations required to market the Licensed Product in the Territory, the execution, delivery and performance of this Agreement by such Party does not require the consent, approval or authorization of, or notice, declaration, filing or registration with, any governmental or Regulatory Authority and the execution, delivery or performance of this Agreement will not violate any law, rule or regulation applicable to such Party;
17
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
(f) this Agreement has been duly authorized, executed and delivered and constitutes such Party’s legal, valid and binding obligation enforceable against it in accordance with its terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of general applicability relating to or affecting creditors” rights and to the availability of particular remedies under general equity principles; and
(g) it shall comply with all applicable material laws and regulations relating to its activities under this Agreement.
10.02 Merck Representation. Merck hereby represents, warrants and covenants to Licensee as follows:
Schedule A contains a complete and accurate listing of the Compound Patent Rights as of the Effective Date [***];
(a) during the Term of this Agreement it will not use in any capacity, in connection with any services to be performed under this Agreement, any individual who has been debarred pursuant to the United States Food, Drug and Cosmetic Act;
(b) it has or will obtain, during the term of this Agreement, the capacity and resources to Develop and Commercialize Licensed Product and to Manufacture Licensed Compound.
18
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
ARTICLE XI – INDEMNIFICATION AND LIMITATION ON LIABILITY
11.02 Indemnification by Merck. [***].
19
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
11.05 [***].
ARTICLE XII – TERM AND TERMINATION
12.02 Termination by Licensee.
20
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
(i) upon or after the breach of any material provision of this Agreement if the breaching Party has not cured such breach within [***] days following receipt of written notice from the non-breaching Party requesting cure of the breach or, if such breach is not susceptible of cure within such sixty [***] day period, the breaching Party has not taken appropriate steps to commence such cure during such [***]-day period and continued to diligently pursue such cure in a manner reasonably assuring such cure within a reasonable period of time thereafter (not to exceed [***] days). Any right to terminate under this Section 12.03(a) shall be stayed and the cure period tolled in the event that, during any cure period, the Party alleged to have been in material breach shall have initiated dispute resolution in accordance with Article XIII with respect to the alleged breach, which stay and tolling shall last so long as the allegedly breaching Party diligently and in good faith cooperates in the prompt resolution of such dispute resolution proceedings; or
(ii) upon the filing or institution of bankruptcy wherein, in the case of filing or institution of bankruptcy of the Licensee, the Licensee fails to use Diligent Efforts to Develop and Commercialize the Licensed Product in the Field in the Territory, reorganization wherein, in the case of reorganization of the Licensee, the Licensee fails to use Diligent Efforts to Develop and Commercialize the Licensed Product in the Field in the Territory, liquidation or receivership proceedings by or against the other Party, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party, or in the event a receiver or custodian is appointed for such Party‘s business, or if a substantial portion of such Party‘s business is subject to attachment or similar process; provided, however, that in the case of any involuntary bankruptcy proceeding, such right to terminate shall only become effective if the proceeding is not dismissed within [***] days after the filing thereof.
(b) Effect of Termination for Cause on License.
12.05 Licensed Product Reversion. [***].
21
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
ARTICLE XIII – DISPUTE RESOLUTION
(a) The arbitration proceeding shall be conducted under the [***] with such proceedings to be held in [***]. In all cases, the arbitration proceedings shall be conducted in the English language, and all documents that are submitted in the proceeding shall be in the English language. Judgment upon the award rendered by arbitration may be issued and enforced by any court having competent jurisdiction.
(b) If a Party intends to begin an arbitration to resolve a dispute, such Party shall provide written notice to the other Party, informing the other Party of such intention and any statement of claim required under the applicable arbitration rules (as determined in accordance with Section 13.02(a)). Within [***] business days after its receipt of such notice, the other Party shall, by written notice to the Party initiating arbitration, add any additional issues to be resolved that would be considered mandatory counterclaims under [***] law. For clarity, the resolution of any disputes regarding such counterclaims shall be conducted in the same proceedings as the initial claims.
(c) [***].
(i) All of the arbitrators shall have significant legal or business experience in pharmaceutical licensing matters. The arbitrators shall not be employees, directors or shareholders of either Party or any of their Affiliates.
22
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
(ii) Each Party shall have the right to be represented by counsel throughout the arbitration proceedings.
(iii) To the extent possible, the arbitration hearings and award will be maintained in confidence.
14.01 Assignment/Change of Control.
23
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
14.02 Governing Law. This Agreement shall be governed, interpreted and construed in accordance with the laws of the State of New York, without giving effect to its conflict of law principles. Subject to the terms of this Agreement, all disputes under this Agreement shall be governed by binding arbitration pursuant to the mechanism set forth in Article XIII herein.
24
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
if to Licensee, to: | Targenics, Inc [***] | |
and: |
25
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
if to Merck, to: | Merck Sharp & Dohme Corp. [***] | |
and | Merck Sharp & Dohme Corp. [***] |
Any such notice shall be deemed to have been received on the earlier of the date actually received or the date [***] days after the same was posted or sent. Either Party may change its address or its facsimile number by giving the other Party written notice, delivered in accordance with this Section 14.07.
26
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
27
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
MERCK, SHARP & DOHME, CORP. | LICENSEE : TARGENICS, INC. | |||||||
By: | /s/ Xxxxx X. Xxxxxxxxx | By: | /s/ Xxxxxx Oft | |||||
Title: | SVP WWLKM | Name: | Xxxxxx Oft | |||||
Title: | ||||||||
By: | /s/ Xxxxx Van Vlasselaer | |||||||
Name: | Xxxxx Van Vlasselaer | |||||||
Title: |
28
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
Schedule A
[***]
[***] | ||||||||
Country | Application Date | [***] | [***] | [***] | ||||
United States | 9/28/2001 | [***] | [***] | [***] | ||||
Austria | 9/28/2001 | [***] | [***] | [***] | ||||
Belgium | 9/28/2001 | [***] | [***] | [***] | ||||
Switzerland | 9/28/2001 | [***] | [***] | [***] | ||||
Switzerland | 9/28/2001 | [***] | [***] | [***] | ||||
United States | [***] | [***] | [***] | [***] | ||||
United States | [***] | [***] | [***] | [***] | ||||
United States | [***] | [***] | ||||||
Germany | 9/28/2001 | [***] | [***] | [***] | ||||
Germany | 9/28/2001 | [***] | [***] | [***] | ||||
European Patent Convention | 9/28/2001 | [***] | [***] | [***] | ||||
European Patent Convention | 9/28/2001 | [***] | [***] | [***] | ||||
Spain | 9/28/2001 | [***] | [***] | [***] | ||||
France | 9/28/2001 | [***] | [***] | [***] | ||||
France | 9/28/2001 | [***] | [***] | [***] | ||||
United Kingdom | 9/28/2001 | [***] | [***] | [***] | ||||
United Kingdom | 9/28/2001 | [***] | [***] | [***] | ||||
Hong Kong | 9/28/2001 | [***] | [***] | [***] | ||||
Ireland | 9/28/2001 | [***] | [***] | [***] | ||||
Italy | 9/28/2001 | [***] | [***] | [***] | ||||
Netherlands | 9/28/2001 | [***] | [***] | [***] |
[***] | ||||||||
Country | Application Date | [***] | [***] | [***] | ||||
Australia | 9/27/2007 | [***] | [***] | [***] | ||||
Brazil | 9/27/2007 | [***] | ||||||
Canada | 9/27/2007 | [***] | ||||||
Switzerland | 9/27/2007 | [***] | [***] | [***] | ||||
Switzerland | 9/27/2007 | [***] | [***] | [***] | ||||
Switzerland | 9/27/2007 | [***] | [***] | [***] | ||||
China | 9/27/2007 | [***] | [***] | [***] | ||||
United States | [***] | [***] | [***] | [***] | ||||
United States | [***] | [***] | [***] | [***] | ||||
United States | [***] | [***] | ||||||
Germany | 9/27/2007 | [***] | [***] | [***] | ||||
Germany | [***] | |||||||
Germany | 9/27/2007 | [***] | [***] | [***] | ||||
European Patent Convention | 9/27/2007 | [***] | [***] | [***] | ||||
European Patent Convention | 9/27/2007 | [***] | [***] | [***] | ||||
European Patent Convention | 9/27/2007 | [***] | [***] | [***] | ||||
Spain | 9/27/2007 | [***] | [***] | [***] | ||||
France | 9/27/2007 | [***] | [***] | [***] | ||||
France | [***] | [***] | [***] | |||||
France | 9/27/2007 | [***] | [***] | [***] | ||||
United Kingdom | 9/27/2007 | [***] | [***] | [***] | ||||
United Kingdom | 9/27/2007 | [***] | [***] | [***] | ||||
United Kingdom | 9/27/2007 | [***] | [***] | [***] | ||||
Hong Kong | 9/27/2007 | [***] | [***] | [***] | ||||
Hong Kong | 9/27/2007 | [***] | ||||||
Italy | 9/27/2007 | [***] | [***] | [***] | ||||
Japan | 9/27/2007 | [***] | [***] | [***] | ||||
Japan | 9/27/2007 | [***] | [***] | [***] | ||||
Japan | 9/27/2007 | [***] | ||||||
Mexico | 9/27/2007 | [***] | [***] | [***] | ||||
Netherlands | 9/27/2007 | [***] | [***] | [***] | ||||
Norway | 9/27/2007 | [***] | ||||||
New Zealand | 9/27/2007 | [***] | [***] | [***] | ||||
Philippines | 9/27/2007 | [***] | [***] | [***] | ||||
South Africa | 9/27/2007 | [***] | [***] | [***] |
[***] | ||||||||
Country | Application Date | [***] | [***] | [***] | ||||
United States | [***] | [***] | [***] | [***] | ||||
Australia | 12/15/2009 | [***] | [***] | [***] | ||||
Australia | 12/15/2009 | [***] | [***] | [***] | ||||
Canada | 12/15/2009 | [***] | [***] | [***] | ||||
China | 12/15/2009 | [***] | [***] | [***] | ||||
China | 12/15/2009 | [***] | [***] | [***] | ||||
United States | [***] | [***] | [***] | [***] | ||||
United States | [***] | [***] | ||||||
United States | [***] | [***] | [***] | [***] | ||||
European Patent Convention | 12/15/2009 | [***] | ||||||
Hong Kong | 12/15/2009 | [***] | [***] | [***] | ||||
India | 12/15/2009 | [***] | ||||||
Japan | 12/15/2009 | [***] | [***] | [***] | ||||
Japan | 12/15/2009 | [***] | ||||||
Russia | 12/15/2009 | [***] | [***] | [***] |
[***]
29
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
Schedule B
[***]
30
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
Schedule C
[***] | ||||||||
Country | Application Date | [***] | [***] | [***] | ||||
United States | 9/28/2001 | [***] | [***] | [***] | ||||
Austria | 9/28/2001 | [***] | [***] | [***] | ||||
Belgium | 9/28/2001 | [***] | [***] | [***] | ||||
Switzerland | 9/28/2001 | [***] | [***] | [***] | ||||
Switzerland | 9/28/2001 | [***] | [***] | [***] | ||||
United States | [***] | [***] | [***] | [***] | ||||
United States | [***] | [***] | [***] | [***] | ||||
United States | [***] | [***] | ||||||
Germany | 9/28/2001 | [***] | [***] | [***] | ||||
Germany | 9/28/2001 | [***] | [***] | [***] | ||||
European Patent Convention | 9/28/2001 | [***] | [***] | [***] | ||||
European Patent Convention | 9/28/2001 | [***] | [***] | [***] | ||||
Spain | 9/28/2001 | [***] | [***] | [***] | ||||
France | 9/28/2001 | [***] | [***] | [***] | ||||
France | 9/28/2001 | [***] | [***] | [***] | ||||
United Kingdom | 9/28/2001 | [***] | [***] | [***] | ||||
United Kingdom | 9/28/2001 | [***] | [***] | [***] | ||||
Hong Kong | 9/28/2001 | [***] | [***] | [***] | ||||
Ireland | 9/28/2001 | [***] | [***] | [***] | ||||
Italy | 9/28/2001 | [***] | [***] | [***] | ||||
Netherlands | 9/28/2001 | [***] | [***] | [***] |
[***] | ||||||||
Country | Application Date | [***] | [***] | [***] | ||||
Australia | 9/27/2007 | [***] | [***] | [***] | ||||
Brazil | 9/27/2007 | [***] | ||||||
Canada | 9/27/2007 | [***] | ||||||
Switzerland | 9/27/2007 | [***] | [***] | [***] | ||||
Switzerland | 9/27/2007 | [***] | [***] | [***] | ||||
Switzerland | 9/27/2007 | [***] | [***] | [***] | ||||
China | 9/27/2007 | [***] | [***] | [***] | ||||
United States | [***] | [***] | [***] | [***] | ||||
United States | [***] | [***] | [***] | [***] | ||||
United States | [***] | [***] | ||||||
Germany | 9/27/2007 | [***] | [***] | [***] | ||||
Germany | [***] | |||||||
Germany | 9/27/2007 | [***] | [***] | [***] | ||||
European Patent Convention | 9/27/2007 | [***] | [***] | [***] | ||||
European Patent Convention | 9/27/2007 | [***] | [***] | [***] | ||||
European Patent Convention | 9/27/2007 | [***] | [***] | [***] | ||||
Spain | 9/27/2007 | [***] | [***] | [***] | ||||
France | 9/27/2007 | [***] | [***] | [***] | ||||
France | [***] | [***] | [***] | |||||
France | 9/27/2007 | [***] | [***] | [***] | ||||
United Kingdom | 9/27/2007 | [***] | [***] | [***] | ||||
United Kingdom | 9/27/2007 | [***] | [***] | [***] | ||||
United Kingdom | 9/27/2007 | [***] | [***] | [***] | ||||
Hong Kong | 9/27/2007 | [***] | [***] | [***] | ||||
Hong Kong | 9/27/2007 | [***] | ||||||
Italy | 9/27/2007 | [***] | [***] | [***] | ||||
Japan | 9/27/2007 | [***] | [***] | [***] | ||||
Japan | 9/27/2007 | [***] | [***] | [***] | ||||
Japan | 9/27/2007 | [***] | ||||||
Mexico | 9/27/2007 | [***] | [***] | [***] | ||||
Netherlands | 9/27/2007 | [***] | [***] | [***] | ||||
Norway | 9/27/2007 | [***] | ||||||
New Zealand | 9/27/2007 | [***] | [***] | [***] | ||||
Philippines | 9/27/2007 | [***] | [***] | [***] | ||||
South Africa | 9/27/2007 | [***] | [***] | [***] |
[***] | ||||||||
Country | Application Date | [***] | [***] | [***] | ||||
United States | [***] | [***] | [***] | [***] | ||||
Australia | 12/15/2009 | [***] | [***] | [***] | ||||
Australia | 12/15/2009 | [***] | [***] | [***] | ||||
Canada | 12/15/2009 | [***] | [***] | [***] | ||||
China | 12/15/2009 | [***] | [***] | [***] | ||||
China | 12/15/2009 | [***] | [***] | [***] | ||||
United States | [***] | [***] | [***] | [***] | ||||
United States | [***] | [***] | ||||||
United States | [***] | [***] | [***] | [***] | ||||
European Patent Convention | 12/15/2009 | [***] | ||||||
Hong Kong | 12/15/2009 | [***] | [***] | [***] | ||||
India | 12/15/2009 | [***] | ||||||
Japan | 12/15/2009 | [***] | [***] | [***] | ||||
Japan | 12/15/2009 | [***] | ||||||
Russia | 12/15/2009 | [***] | [***] | [***] |
31
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
CONFIDENTIAL TREATMENT REQUESTED
Schedule D
[***]
32
*** CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.