LICENSE AGREEMENT
Exhibit 10.9
***OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION
CONFIDENTIAL TREATMENT REQUESTED
This License Agreement (“Agreement”) is entered into as of this 21st day of March, 2012 (the “Effective Date”), by and between Ember Therapeutics, Inc., having a place of business at 000 Xxxxxxxx Xxxxxx, 00xx Xxxxx, Xxxxxx, XX 00000 (“Licensee”), and Xxxxxx Diabetes Center, having a place of business at Xxx Xxxxxx Xxxxx, Xxxxxx, Xxxxxxxxxxxxx 00000 (“Joslin”).
WHEREAS, Joslin is the owner of the Licensed Patents (as defined below) and has the right to grant licenses thereunder; and
WHEREAS, Licensee wishes to obtain a license under the Licensed Patents and Xxxxxx wishes to grant Licensee a license under the Licensed Patents, all in accordance with the terms and conditions of this Agreement.
NOW, THEREFORE, the parties hereto, intending to be legally bound, hereby agree as follows:
1. | Definitions. |
Whenever used in this Agreement with an initial capital letter, the terms defined in this Section 1, whether used in the singular or the plural, have the meanings specified below.
1.1 “Affiliate” means, with respect to an entity, any person, organization or entity controlling, controlled by or under common control with, such entity. For purposes of this definition only, “control” of another person, organization or entity will mean the possession, directly or indirectly, of the power to direct or cause the direction of the activities, management or policies of such person, organization or entity, whether through the ownership of voting securities, by contract or otherwise. Without limiting the foregoing, control will be presumed to exist when a person, organization or entity (a) owns or directly controls fifty percent (50%) or more of the outstanding voting stock or other ownership interest of the other organization or entity, or (b) possesses, directly or indirectly, the power to elect or appoint fifty percent (50%) or more of the members of the governing body of the organization or other entity. The parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such cases such lower percentage will be substituted in the preceding sentence.
1.2 “Calendar Quarter” means each of the 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.
1.3 “Confidential Information” means any and all scientific, technical, financial, operational, marketing, economic, business or other information in whatever form (written, oral or visual) that is furnished or made available to one party (a “Recipient”) by or on behalf of the other party (a “Discloser”), and that (i) if in tangible form, is labeled in writing as proprietary or confidential; (ii) if in oral
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or visual form, is identified as proprietary or confidential by the Discloser at the time of disclosure or within thirty (30) days thereafter; or (iii) whether or not labeled or otherwise identified by Discloser as confidential or proprietary, should be deemed to be confidential or proprietary by a reasonable person given the nature of the information and/or the circumstances under which it was disclosed. Confidential Information includes, without limitation, trade secrets, patterns, plans, compilations, programs, devices, formulas, designs, prototypes, methods, techniques, processes, procedures, know-how, inventions, codes, software, data and databases, product names, marks, marketing materials and programs, specifications and materials.
1.4 “Derivative Information” means all copies, digests, summaries and extracts of the Discloser’s Confidential Information created or maintained by Recipient, its employees or consultants. Recipient agrees to treat any Derivative Information in accordance with the non-disclosure and non-use provisions of this Agreement that apply to Discloser’s Confidential Information. Additionally, for the avoidance of doubt, any of the Discloser’s Confidential Information included in any Derivative Information is owned by the Discloser of such Confidential Information,
1.5 “FDA” means the United States Food and Drug Administration.
1.6 “Field” means discovery, development, and commercialization of products and services for the prevention, palliation, treatment, or cure of diseases in animals and humans.
1.7 “IND” means an application for approval to conduct human clinical investigations that satisfies the requirements of 21 C.F.R. 312.
1.8 “Licensed Patents” means (a) the patents and patent applications listed in Exhibit A (such applications hereafter referred to as “Patent Applications”); (b) any patent issuing on any such Patent Applications; and (c) all divisions, requests for continued examination, continuations, continuations-in-part (but only to the extent that the claims of each such continuation-in-part application are directed to subject matter specifically described in the Patent Applications), re-examinations, reissues, substitutions, or extensions thereof and patent issuing from those patent rights described in (a) or (b) above and this (c), and (d) foreign counterparts (including supplementary protection certificates) to any such patent rights.
1.9 “Licensed Product” means products, devices, or compositions, the manufacture, use or sale of which falls within the scope of a Valid Claim in the Field.
1.10 “Net Sales” means the gross amount billed or invoiced by or on behalf of Licensee and its Affiliates and Sublicensees (in each case, the “Invoicing Entity”) on sales of Licensed Products, less the following to the extent applicable on such sales of Licensed Products and not previously deducted from the gross invoice price: (a) customary trade, quantity or cash discounts, rebates, allowances and retroactive price adjustments to the extent actually allowed and taken; (b) amounts actually repaid or credited by reason of rejection or, return or recall of any previously sold, leased or otherwise transferred Licensed Products; (c) charge-backs and similar amounts paid to distributors and wholesalers in the ordinary course of business, (d) customer freight charges that are paid by or on behalf of the Invoicing Entity; (e) invoiced
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amounts that are determined to be bad debt and (f) to the extent separately stated on purchase orders, invoices or other documents of sale, any sales, value added or similar taxes, custom duties or other similar governmental charges levied directly on the production, sale, transportation, delivery or use of a Licensed Product that are paid by or on behalf of the Invoicing Entity, but not including any tax levied with respect to income; provided that (i) in any transfers of Licensed Products between an Invoicing Entity and an Affiliate of such Invoicing Entity not for the purpose of resale by such Affiliate, Net Sales will be equal to the fair market value of the Licensed Products so transferred, assuming an arm’s length transaction made in the ordinary course of business, and (ii) sales of Licensed Products by an Invoicing Entity to its Affiliate or Sublicensee for resale by such Affiliate or Sublicensee will not be deemed Net Sales. Instead, Net Sales will be determined based on the gross amount billed or invoiced by such Affiliate or Sublicensee on resale of Licensed Products to a third party purchaser.
In the event Licensee or an Affiliate or Sublicensee (each a “Combination Product Seller”) uses a proprietary (whether proprietary to a Combination Product Seller or a third party) active ingredient or component not licensed by Xxxxxx to Licensee hereunder (“Other Components”) to form a product that is a combination of a Licensed Product and an Other Component(s) (a “Combination Product”), Net Sales for the purposes of calculating the royalty owed to Xxxxxx on sales of such Product shall be calculated as described in the subsections below:
(i) If the Licensed Product and Other Components contained in the Combination Product(s) are sold separately, Net Sales for sales of the Licensed Product for the purposes of calculating royalty payments shall be determined by multiplying the greater of the gross amount billed or invoiced, or if no such xxxx or invoice is issued the amount received, by the Combination Product Seller for or on account of sales of such Combination Product (the “Gross Sales Price”) by the fraction A/(A+B), in which “A” is the Gross Sales Price of the Licensed Product portion of the Combination Product when sold separately during the most recent reporting period in the country in which the sale was made, and “B” is the Gross Sales Price of the Other Components of the Combination Product sold separately during said reporting period in said country.
(ii) If either the Licensed Product or the Other Components constituting the Combination Product are not sold separately in the relevant country during the most recent reporting period then the Parties shall negotiate in good faith towards an allocation of the Net Sales of the Combination Product between the Licensed Product (which amount shall be royalty bearing) and the Other Components (which amount shall not be royalty bearing).
1.11 “Non-Royalty Sublicense Income” means any payments or other consideration that Licensee or any of its Affiliates receives in consideration for a Sublicense, other than
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royalties based on Net Sales, including without limitation license fees, milestone payments, equity investments to the extent the amount paid for such equity exceeds its fair market value, up front fees, success fees, minimum annual payments and license maintenance fees, but excluding payments for patent expenses, research, development, manufacturing or commercialization activities (including payments for personnel, whether calculated or paid on a fulltime equivalent basis or otherwise) or similar payments to the extent not in excess of the actual cost to Licensee, loans, and equity investments to the extent the amount paid for such equity does not exceed its fair market value. To the extent that rights other than rights under the Licensed Patents are granted along with a Sublicense, the consideration received by Licensee will be apportioned between the Sublicense and such other rights pursuant to good faith negotiations between Licensee and Xxxxxx. In the event the parties are unable to reach agreement on such apportionment, the apportionment shall be determined pursuant to Sections 12.6(b) and (c) of this Agreement. For the avoidance of doubt, Non-Royalty Sublicense Income shall not include proceeds obtained from the sale of Licensee or that portion of Licensee’s business to which this Agreement relates.
1.12 “Phase 2 Clinical Trial” means a human clinical trial that satisfies the requirements of 21 C.F.R. § 312.21 (b).
1.13 “Regulatory Authority” means any applicable government regulatory authority involved in granting approvals for the manufacturing, marketing, reimbursement and/or pricing of a Licensed Product.
1.14 “Sublicense” means any license given or agreement entered into by Licensee to or with any other person or entity, under or with respect to or permitting any use of any of the Licensed Patents, or otherwise permitting the development, manufacture, marketing, distribution and/or sale of Licensed Products. For avoidance of doubt, sublicenses granted to service providers acting for the benefit of Licensee shall not constitute “Sublicenses”.
1.15 “Sublicensee” means any person or entity granted a Sublicense.
1.16 “Third Party” means any person or entity other than Licensee or Xxxxxx or any of their Affiliates
1.17 “Valid Claim” will mean: (a) a claim of an issued and unexpired patent within the Licensed Patents that has not been (i) held permanently revoked, unenforceable, unpatentable or invalid by a decision of a court or governmental body of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, (ii) rendered unenforceable through disclaimer or otherwise, (iii) abandoned, or (iv) permanently lost through an interference or opposition proceeding without any right of appeal or review; or (b) a pending claim of a pending patent application within the Licensed Patents that (i) has been asserted and continues to be prosecuted in good faith and (ii) has not been pending in excess of five (5) years and (iii) has not been abandoned or finally rejected without the possibility of appeal or refiling.
2. | License Grants. |
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(a) Xxxxxx will retain the right to practice the Licensed Patents for non-commercial, non-clinical research (provided such research is not sponsored by any for-profit entity), teaching and other educational purposes only, and the right to permit governmental laboratories and other not-for-profit research institutions to practice the Licensed Patents for the foregoing purposes; and
(b) the U.S. federal government will retain rights in the Licensed Patents pursuant to 35 U.S.C. §§ 200-212 and 37 C.F.R. § 401 et seq., and any right granted in this Agreement greater than that permitted under 35 U.S.C. §§ 200-212 or 37 C.F.R. § 401 et seq. will be subject to modification as may be required to conform to the provisions of those statutes and regulations.
2.2 Sublicenses.
(a) Licensee is entitled to grant Sublicenses to third parties under the license granted pursuant to Section 2.1. All Sublicenses will be on terms and conditions in compliance with and not inconsistent with the terms of this Agreement.
(b) Sublicenses will be granted only pursuant to written agreements, which will be subject and subordinate to the terms and conditions of this Agreement. Such Sublicense agreements will contain, among other things, the following:
(i) all provisions necessary to ensure Licensee’s ability to perform its obligations under this Agreement;
(ii) a section substantially the same as Section 9 (Indemnification), which also will state that the Indemnitees (as defined in Section 9) are intended third party beneficiaries of such Sublicense agreement for the purpose of enforcing such indemnification and insurance provisions;
(iii) in the event of termination of this Agreement by Xxxxxx pursuant to Section 10.3, (in whole or in part (e.g., termination in a particular country)), any existing Sublicense will terminate; provided, however, that, such Sublicense will not terminate if, as of the effective date of such termination by Xxxxxx pursuant to Section 10.3, a Sublicensee is not in material default of its obligations to Licensee under its Sublicense agreement, and within thirty (30) days of such termination the Sublicensee agrees in writing to be bound directly to Xxxxxx under a license agreement
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substantially similar to this Agreement with respect to the rights Sublicensed hereunder, substituting such Sublicensee for Licensee; and
(iv) any permitted assignee must agree in writing to be bound by the terms of the assigned Sublicense agreement.
(c) Notwithstanding anything to the contrary in 2.2(b) above, (i) Licensee shall furnish Xxxxxx with a fully executed copy of any such Sublicense agreement, within thirty (30) days after its execution, which copy may be redacted to exclude financial and other sensitive terms and shall be treated as Confidential Information of Licensee hereunder. Xxxxxx shall keep any such copies of Sublicense agreements in its confidential files and shall use them solely for the purpose of monitoring Licensee’s and Sublicensees’ compliance with their obligations hereunder and enforcing Xxxxxx’x rights under this Agreement; (ii) Licensee shall report to Xxxxxx annually the progress of Sublicensees’ in developing and marketing Licensed Products; and (iii) Licensee shall monitor Sublicensees’ development efforts under the Sublicenses to assess reasonable and continuous progress in developing Licensed Products to commercial application.
(d) During the term of this Agreement, Licensee shall be responsible for any breach of a Sublicense agreement by any Sublicensee that results in a material breach of this Agreement. Licensee may elect (a) to cure such breach in accordance with Section 10.3 of this Agreement or (b) to enforce its rights by terminating such Sublicense agreement in accordance with the terms thereof.
(a) no such Affiliate will be entitled to grant, directly or indirectly, to any third party any right of whatever nature under, or with respect to or permitting any use or exploitation of any of the Licensed Patents, including any right to develop, manufacture, market or sell Licensed Products; and
(b) any act or omission taken or made by an Affiliate of Licensee under this Agreement will be deemed an act or omission by Licensee under this Agreement.
3. | Development and Commercialization. |
(a) Licensee will deliver a written development plan to Xxxxxx within one hundred twenty (120) days of the Effective Date (the “Development Plan”), which Development Plan will summarize Licensee’s plans to utilize the Licensed Patents for the development and commercialization of a Licensed Product.
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3.2 Annual Reporting and Meetings.
(a) Within forty-five (45) days after each anniversary of the Effective Date, Licensee will furnish Xxxxxx with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain approvals from the FDA or any other Regulatory Authority, marketing efforts and sales figures. The written report will contain a sufficient level of detail to assess whether Licensee is in compliance with its obligations under Section 3.3 below and shall also contain a discussion of intended efforts and sales projections for the then current year.
(b) The parties will meet at least two (2) times per contract year during the first two
(2) years following the Effective Date, and at least on an annual basis thereafter, or as otherwise agreed by the parties, at such times as are agreed by the parties. Such meetings may be in-person, via videoconference, or via teleconference, provided that at least one (1) meeting per contract year will be held in person. During such meetings, Licensee will provide Xxxxxx with a summary of (i) its efforts to develop and commercialize Licensed Products as detailed in the annual report discussed in Section 3.2(a) during the period since submission of the previous such annual report and/or since the last meeting, (ii) its strategy and activities relating to the grant of Sublicenses, including, for example, a description of the corporate profile of Sublicensees it is actively pursuing, the anticipated Sublicense terms and the geographies in respect of which it anticipates granting Sublicenses and (iii) progress towards the accomplishment of any of the milestone events described in Section 4.3 that Licensee reasonably anticipates achieving within the next twelve (12) month period.
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If Xxxxxx determines that Licensee has not fulfilled its obligations under this Section 3.3, Xxxxxx shall furnish Licensee with written notice of the determination. Within sixty (60) days after Licensee’s receipt of the notice described in the preceding sentence, Licensee shall either (i) fulfill the relevant obligation, (ii) negotiate with Xxxxxx a mutually acceptable schedule of revised commercialization obligations, or (iii) dispute Xxxxxx’x assertions and initiate dispute resolution under Section 12.6. Notwithstanding the foregoing, Xxxxxx shall not have the right to terminate this Agreement for a failure to meet the requirements of this Section 3.3 if Licensee shows progress in development or commercialization of at least one Licensed Product during the preceding twelve (12) month period.
4. | Consideration for Grant of License |
4.1 Equity.
(a) Within thirty (30) days after the Effective Date, Licensee shall issue to Xxxxxx fifty thousand (50,000) shares of common stock of Licensee and Licensee shall provide Xxxxxx with a copy of Licensee’s capitalization table on the Effective Date.
(b) Within thirty (30) days after the first IND for a Licensed Product becomes effective (that is, Licensee is permitted to dose subjects with a Licensed Product consistent with FDA regulations), Licensee shall issue to Xxxxxx one hundred thousand (100,000) shares of common stock of Licensee.
4.2 Upfront Fees. Licensee shall pay Xxxxxx an upfront fee of $25,000 within fifteen (15) days following the Effective Date (the “Upfront Fee”).
4.3 Milestone Payments.
(a) Licensee shall make milestone payments to Xxxxxx upon achievement of each of the milestones events as set forth below by Licensee, its Affiliates or Sublicensees. Licensee shall notify Xxxxxx in writing within thirty (30) days following the achievement by Licensee, its Affiliates or Sublicensees of each milestone event described in this Section 4.3, and shall make the appropriate milestone payment within thirty (30) days after the achievement of such milestone event with respect to the first Licensed Product. Each milestone payment shall become payable hereunder a maximum of one time no matter how many times any of the milestone events are achieved and no matter whether the milestone events are achieved by Licensee, its Affiliates or Sublicensees:
(i) [***] after the first IND for a Licensed Product becomes effective (that is, Licensee (or an Affiliate or Sublicensee) is permitted to dose subjects with a Licensed Product consistent with FDA regulations);
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(ii) [***] upon completion of the first Phase 2 Clinical Trial with respect to a Licensed Product;
(iii) [***] upon the grant of marketing approval by FDA with respect to a Licensed Product; and
(iv) [***] upon reaching aggregate Net Sales of [***] of a Licensed Product in a calendar year.
The milestones set forth in Section 4.3 are intended to be successive. In the event that a Licensed Product is not required to undergo the testing associated with a particular milestone (“Skipped Milestone”), such Skipped Milestone will be deemed to have been achieved at the time it is determined that the Licensed Product is not required to undergo the said testing. Payment for any Skipped Milestone that is owed in accordance with the provisions of this Section 4.3 will be due within thirty (30) days from the date it is deemed to be a Skipped Milestone. Any amounts paid under this Section 4.3 shall be fully creditable against amounts that become due under Section 4.5.
4.4 Royalties.
(a) Rate. Licensee shall pay to Xxxxxx royalties, on a country-by-country and product- by-product basis, an amount equal to [***] percent ([***]%) of Net Sales of Licensed Products.
(b) Third Party Payment Set-Off. Licensee may offset [***] percent ([***]%) of any payments made to a third party that are directly related to the acquisition of intellectual property rights or technology used for the development, manufacture or commercialization of Licensed Products, provided that in no event shall the royalty payments to Xxxxxx be reduced by more than [***] percent ([***]%) of the amount otherwise due.
4.5 Non-Royalty Sublicense Income. Licensee shall pay Xxxxxx a percentage of all Non-Royalty Sublicense Income as specified in the following table, provided that Licensee’s obligation to make payments under this Section 4.5 shall expire when Licensee has paid Xxxxxx cumulative, total payments of Non-Royalty Sublicense Income equal to [***].
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Effective Date of Sublicense | Percentage of Non-Royalty Sublicense Income | |
Prior to the first anniversary of the Effective Date | [***]% | |
After the first anniversary of the Effective Date but on or before the second anniversary of the Effective Date | [***]% | |
After the second anniversary of the Effective Date but on or before the fifth anniversary of the Effective Date |
[***]% | |
After the fifth anniversary of the Effective Date | [***]% |
5. | Reports; Payments; Records. |
(a) Within ninety (90) days after the conclusion of each Calendar Quarter commencing with the first Calendar Quarter in which Net Sales are generated or Non-Royalty Sublicense Income is received, Licensee shall deliver to Xxxxxx a report containing the following information (in each instance, with a Licensed Product-by-Licensed Product and country-by-country breakdown):
(i) the number of units of Licensed Products sold by Licensee, its Affiliates and Sublicensees for the applicable Calendar Quarter;
(ii) the gross amount invoiced for Licensed Products sold by Licensee, its Affiliates and Sublicensees during the applicable Calendar Quarter;
(iii) a calculation of Net Sales for the applicable Calendar Quarter, including an itemized listing of allowable deductions;
(iv) a detailed accounting of all Non-Royalty Sublicense Income received during the applicable Calendar Quarter; and
(v) | the total amount payable to Xxxxxx in U.S. Dollars on Net Sales and Non- Royalty Sublicense Income for the applicable Calendar Quarter, together with the exchange rates used for conversion. |
Each such report will be certified on behalf of Licensee as true, correct and complete in all material respects. If no amounts are due to Xxxxxx for a particular Calendar Quarter, the report will so state.
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(b) Within ninety (90) days of the end of each Calendar Quarter, Licensee shall pay Xxxxxx all amounts due with respect to Net Sales and Non-Royalty Sublicense Income for the applicable Calendar Quarter.
(c) All payments due under this Agreement will be payable in U.S. Dollars. Conversion of foreign currency to U.S. Dollars will be made at the conversion rate existing in the United States (as reported in the Wall Street Journal) on the last working day of the applicable Calendar Quarter. Such payments will be without deduction of exchange, collection, or other charges.
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be deducted from the payment to be made by Licensee and remitted to the appropriate taxing authority for the benefit of Xxxxxx. Licensee will withhold only such amounts as are required to be withheld by applicable law in the country from which payment is being made. Licensee shall submit to Xxxxxx originals of the remittance voucher and the official receipt evidencing the payment of the corresponding taxes with the applicable royalty report, if possible, or within ten
(10) business days thereafter. Licensee will cooperate with Xxxxxx to provide such information and records as Xxxxxx may require in connection with any application by Xxxxxx to the tax authorities in any country, including attempt to obtain an exemption or a credit for any withholding tax paid in any country.
6. | Patent Filing, Prosecution and Maintenance. |
(d) supply Licensee with a copy of the application as filed, together with notice of its filing date and serial number; (e) keep Licensee advised of the status of actual and prospective patent filings; and (f) provide copies of any papers related to the filing, prosecution, protection and maintenance of such patent filings at least thirty (30) days in advance of filing or use of same. Xxxxxx shall give Licensee the opportunity to provide comments on and make requests of Xxxxxx concerning the preparation, filing, prosecution and maintenance of the Licensed Patents, and shall consider such comments and requests in good faith.
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7. | Enforcement of Licensed Patents. |
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sums recovered, Xxxxxx shall receive out of any such remaining recovery received by Licensee an amount as follows: (i) as to ordinary damages, Xxxxxx shall receive payment equivalent to payments that would have been due to Xxxxxx under this Agreement had the infringing sales that Licensee lost to the infringer been made by Licensee and (ii) as to special or punitive damages, such amount shall be divided seventy-five percent (75%) to Licensee and twenty-five percent (25%) to Xxxxxx.
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8. | Warranties; Limitation of Liability. |
8.1 Warranties.
(a) Licensee represents and warrants that it will comply, and will ensure that its Affiliates and Sublicensees comply, with all local, state, and international laws and regulations relating to the development, manufacture, use, sale and importation of Licensed Products. Without limiting the foregoing, Licensee represents and warrants that it will comply, and will ensure that its Affiliates and Sublicensees will comply, with all United States export control laws and regulations with respect to Licensed Products.
(b) Xxxxxx represents and warrants to Licensee that, to the best of its knowledge, as of the Effective Date: (i) the Licensed Patents have been prosecuted in good faith; (ii) all fees required to maintain the effectiveness of all patent applications and patents within the Licensed Patents have been paid; (iii) all inventors of the inventions disclosed in the Licensed Patents have duly assigned their rights therein to Xxxxxx; (iv) except for the rights and licenses granted to Licensee herein, Xxxxxx has not granted any Third Party any rights, licenses or options to practice the inventions disclosed in the Licensed Patents, and (vi) Xxxxxx has no knowledge of any claims asserting that the practice of the inventions claimed by the Licensed Patents constitutes an infringement or misappropriation of the rights of any Third Party.
8.2 No Warranty.
(a) NOTHING CONTAINED HEREIN WILL BE DEEMED TO BE A WARRANTY BY XXXXXX THAT IT CAN OR WILL BE ABLE TO OBTAIN PATENTS ON PATENT APPLICATIONS INCLUDED IN THE LICENSED PATENTS, OR THAT ANY OF THE LICENSED PATENTS WILL AFFORD ADEQUATE OR COMMERCIALLY WORTHWHILE PROTECTION.
(b) XXXXXX DOES NOT MAKE ANY REPRESENTATION THAT THE PRACTICE OF THE LICENSED PATENTS, THE DEVELOPMENT, MANUFACTURE, USE, SALE OR IMPORTATION OF ANY LICENSED PRODUCT OR ANY ELEMENT THEREOF, WILL NOT INFRINGE THE PATENT OR PROPRIETARY RIGHTS OF ANY THIRD PARTY.
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(c) EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, XXXXXX AND LICENSEE EACH MAKE NO WARRANTIES WITH RESPECT TO ANY TECHNOLOGY, PATENTS, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT WITH RESPECT TO ANY AND ALL OF THE FOREGOING.
9. | Indemnification. |
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Licensee’s receipt of an Indemnification Claim Notice. The assumption of the defense of a Third Party Claim by Licensee shall not be construed as an acknowledgment that Licensee is liable to indemnify the Claiming Indemnitee in respect of the Third Party Claim, nor shall it constitute a waiver by Licensee of any defenses it may assert against the Claiming Indemnitee’s claim for indemnification. Upon assuming the defense of a Third Party Claim, Licensee may appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by Licensee. In the event Licensee assumes the defense of a Third Party Claim, the Claiming Indemnitee shall immediately deliver to Licensee all original notices and documents (including court papers) received by the Claiming Indemnitee in connection with the Third Party Claim. If Licensee assumes the defense of a Third Party Claim, Licensee shall not be liable to the Claiming Indemnitee for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense or settlement of the Third Party Claim. In the event that it is ultimately determined that Licensee is not obligated to indemnify, defend or hold harmless the Claiming Indemnitee from and against the Third Party Claim, the Claiming Indemnitee shall reimburse Licensee for any and all costs and expenses (including attorneys’ fees and costs of suit) and any Third Party Claims incurred by Licensee in its defense of the Third Party Claim.
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respect to or settle, compromise or discharge, any Third Party Claim without the prior written consent of Licensee, such consent not to be unreasonably withheld or delayed.
9.8 Insurance.
(a) Beginning at the time any Licensed Product is being commercially distributed or sold (other than for the purpose of obtaining regulatory approvals) by Licensee, or by an Affiliate, Sublicensee or agent of Licensee, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than $1,000,000 per incident and $2,000,000 annual aggregate and naming Xxxxxx as an additional insured. During clinical trials of any such Licensed Product, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in such equal or lesser amount as Xxxxxx will require, naming Xxxxxx as an additional insured. Such commercial general liability insurance will provide: (i) product liability coverage and (ii) broad form contractual liability coverage for Licensee’s indemnification under this Agreement.
(b) If Licensee elects to self-insure all or part of the limits described above in Section 10.2.1 (including deductibles or retentions which are in excess of $250,000 annual aggregate) such self-insurance program must be acceptable to Xxxxxx in its sole discretion. The minimum amounts of insurance coverage required will not be construed to create a limit of Licensee’s liability with respect to its indemnification under this Agreement.
(c) Licensee shall provide Xxxxxx with written evidence of such insurance upon request of Xxxxxx. Licensee shall provide Xxxxxx with written notice at least fifteen (15) days prior to the cancellation, non-renewal or material change in such
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insurance; if Licensee does not obtain replacement insurance providing comparable coverage within such fifteen (15) day period, Xxxxxx will have the right to terminate this Agreement effective at the end of such fifteen (15) day period without notice or any additional waiting periods.
(d) Licensee shall maintain such commercial general liability insurance beyond the expiration or termination of this Agreement during: (i) the period that any Licensed Product is being commercially distributed or sold by Licensee, or an Affiliate, Sublicensee or agent of Licensee; and (ii) a reasonable period after the period referred to in (i)above.
10. | Term and Termination. |
10.2 Termination by Licensee. Licensee may terminate this Agreement upon sixty
(60) days prior written notice to Xxxxxx.
(a) Upon termination of this Agreement by Xxxxxx pursuant to Section 10.3, or by Licensee pursuant to Section 10.2, the rights and licenses granted to Licensee under Section 2.1 will terminate and all rights in and to and under Xxxxxx’x interest in the Licensed Patents will revert to Xxxxxx.
(b) Upon commission by Xxxxxx of an uncured breach of this Agreement as provided in Section 10.3, Licensee shall be permitted to either: (i) terminate this Agreement and the rights and licenses granted to Licensee under Section 2.1 will terminate and all rights in and to and under Xxxxxx’x interest in the Licensed Patents will revert to Xxxxxx; or (ii) Licensee may, by notice to Xxxxxx, opt to continue the effectiveness of the Agreement (the “Continuation Option”), provided that all payment obligations under Section 4 shall be reduced by [***] percent ([***]%)
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commencing on the date of breach of this Agreement by Xxxxxx and continuing for the remainder of the term of this Agreement and the Agreement shall otherwise remain in full force and effect in accordance with its terms.
(c) Termination or expiration of this Agreement will not relieve the parties of obligations accruing prior to such termination or expiration, including obligations to pay amounts accruing hereunder up to the date of termination or expiration. After the date of termination or expiration, Licensee, its Affiliates and Sublicensees (i) may sell Licensed Products then in stock and (ii) may complete the production of Licensed Products then in the process of production and sell the same; provided in the case of both (i) and (ii) that Licensee shall pay the applicable royalties and payments to Xxxxxx in accordance with Section 4.4, provide reports and audit rights to Xxxxxx pursuant to Section 5 and maintain insurance in accordance with the requirements of Section 9.8.
(d) In the event Xxxxxx terminates this Agreement pursuant to Section 10.3, Licensee shall promptly provide Xxxxxx with the right to reference, cross-reference, review, have access to, incorporate and use all documents and other materials filed by or on behalf of Licensee and its Affiliates with any Regulatory Authority in furtherance of applications for marketing approval in the relevant country with respect to Licensed Products. Xxxxxx will be entitled to freely use and to grant others the right to use all such materials, documents and know-how delivered pursuant to this Section 10.4(d).
10.5 The parties’ respective rights, obligations and duties under Sections: 5.2, 5.3, 5.4, 8.3, 9.1 – 9.7 (inclusive), 10.4, 11.1 – 11.5 (inclusive), 12.2, 12.4, 12.5 and 12.6, as well as any rights, obligations and duties which by their nature extend beyond the expiration or termination of this Agreement, will survive any expiration or termination of this Agreement. In addition, Licensee’s obligations under Section 5.5 with respect to Sublicenses granted prior to termination of the Agreement will survive termination.
11. | Confidentiality. |
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(a) | is generally known to the public at the time of disclosure or becomes generally known through no wrongful act on the part of Recipient; |
(b) | is in Recipient’s possession at the time of disclosure other than as a result of Recipient’s breach of any legal obligation; |
(c) | becomes known to Recipient on a non-confidential basis through disclosure by sources other than Discloser having the legal right to disclose such Confidential Information; or |
(d) | is independently developed by Recipient without reference to or reliance upon Discloser’s Confidential Information. |
If Recipient is required by a governmental authority or by order of a court of competent jurisdiction to disclose any of Discloser’s Confidential Information, Recipient will give Discloser prompt written notice thereof and Recipient will take all reasonable and lawful actions to avoid or minimize the degree of such disclosure. Recipient will cooperate reasonably with Discloser in any efforts to seek a protective order.
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Recipient will return all of Discloser’s Confidential Information (which will include returning any of Discloser’s Confidential Information included in Derivative Information, with Recipient’s Confidential Information or third party confidential information redacted) and will provide a written certification to Discloser certifying that all of Discloser’s Confidential Information has been returned. Recipient may, however, retain one (1) copy of Discloser’s Confidential Information in its confidential files, solely for the purpose of monitoring its continuing obligations of confidentiality and non-use under this Agreement.
12. | Miscellaneous. |
If to Licensee: | Ember Therapeutics, Inc.
000 Xxxxxxxx Xxxxxx, 00xx Xxxxx Xxxxxx, XX 00000 Attn: Chief Executive Officer |
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Copy to:
Xxxxxxx Procter LLP 00 Xxxxx Xxxxxx Xxxxxx, XX 00000 Attn: Xxxxxxxxxxx Xxxx | |
If to Joslin: | Xxxxxx Diabetes Center, Inc. Xxx Xxxxxx Xxxxx Xxxxxx, XX 00000 Attn: General Counsel |
Any notice will be deemed to have been received as follows: (a) by personal delivery, upon receipt; (b) by facsimile, one business day after transmission or dispatch; (c) by airmail, seven (7) business days after delivery to the postal authorities by the party serving notice. If notice is sent by facsimile, a confirming copy of the same will be sent by mail to the same address.
12.5 Governing Law and Venue. Subject to Section 12.6, this Agreement will be governed by, and construed in accordance with, the substantive laws of the Commonwealth of Massachusetts, without giving effect to any choice or conflict of law provision, except that questions affecting the construction and effect of any patent will be determined by the law of the country in which the patent will have been granted.
(a) In the event of a dispute between the parties, the parties shall first attempt in good faith to resolve such dispute by negotiation and consultation between themselves. In the event that such dispute is not resolved on an informal basis within forty- five (45) days, any party may, by written notice to the other, have such dispute referred to each of the parties’ respective senior officers, who shall attempt in good faith to resolve such dispute by negotiation and consultation for a thirty (30) day period following receipt of such written notice.
(b) In the event the parties’ senior officers are not able to resolve such dispute, either party may at any time after such 30-day period submit such dispute to be finally settled by arbitration administered in accordance with the Commercial Arbitration Rules of the American Arbitration Association (“AAA”) in effect at the time of submission. The arbitration shall be heard and determined by three (3) arbitrators. Licensee and Xxxxxx shall each appoint one arbitrator and the third arbitrator shall
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be selected by the two party-appointed arbitrators, or, failing agreement within sixty (60) days following the date of receipt by the respondent of the claim, by the AAA. Such arbitration shall take place in Boston, Massachusetts. The arbitration award so given shall be a final and binding determination of the dispute, shall be fully enforceable in any court of competent jurisdiction, and shall not include any damages expressly prohibited by Section 8.3.
(c) Costs of arbitration are to be divided by the parties in the following manner: Licensee shall pay for the arbitrator it chooses, Xxxxxx shall pay for the arbitrator it chooses, and the costs of the third arbitrator shall be divided equally between the parties. Except in a proceeding to enforce the results of the arbitration or as otherwise required by law, neither party nor any arbitrator may disclose the existence, content or results of any arbitration hereunder without the prior written consent of both parties.
(d) Each party shall continue to performits obligations under this Agreement pending final resolution of any dispute arising out of or relating to this Agreement. However, a party may suspend performance of its obligations during any period in which the other party fails or refused to perform its obligations.
(e) Although the procedures specified in this Section 12.6 are the exclusive procedures for resolution of disputes arising out of or relating to this Agreement, either party may seek a preliminary injunction or other provisional equitable relief if, in its reasonable judgment, that action is necessary to avoid irreparable harm to itself or to preserve its rights under this Agreement.
(f) The parties agree that all applicable statutes of limitation and time-based defenses (such as estoppel and laches) are tolled while the procedures set forth in this Section 12.6 are pending. The parties shall take any actions necessary to effectuate this result.
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of the breach of any term contained in this Agreement, whether by conduct, or otherwise, in any one or more instances, will be deemed to be, or considered as, a further or continuing waiver of any such condition or of the breach of such term or any other term of this Agreement.
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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly authorized representatives as of the date first written above.
By: /s/ Xxxxx X. Xxxxxxxxx Name: Xxxxx X. Xxxxxxxxx Title: CEO |
By: /s/ Xxxxxx Padukone Name: Xxxxxx Padukone Title: VP Commercialization and Ventures |
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Exhibit A Licensed Patents
Xxxxxx No. | Inventors | IDR Title | U.S. and foreign patent application/patent numbers |
JDP-088 | Xxxxxx Diabetes Center: Xxxxxx X. Xxxx, Yu-Xxx Xxxxx.
Children’s Hospital: Xxxx Xxxxx |
“Methods and Compositions for Modulating Adipocye Function” | U.S. Patent App. No. 12/502551, file date Jul 14, 2009.
U.S. Patent, Granted, No 7576052, Grant Date 18-Aug- 2009; Original filing 10/968791, filing date 18- Oct-2004.
PCT Nationalized PCT/US2004/034491, file date 18-Oct-2004;
Nationalized PCT European Patent Office Serial No. 04795629.7, file date 00- Xxx-0000; |
XXX-000 | Xxxxxx Diabetes Center: Yu-Xxx Xxxxx; Xxxxxxxx Xxxxxxxx | “Bone Morphogenetic Proteins for Appetite Control” | U.S. Prov. App. No. 61/179977, file date 20-May- 2009.
U.S. Patent App. No. 12/784228, file date May 20- 2010. |
JDP-137 | Xxxxxx Diabetes Center: Yu-Xxx Xxxxx; Xxxxxx X. Xxxx | “Bone Morphogenetic Proteins for The Treatment of Insulin Resistance” | U.S. Prov. App. No. 61/180371, file date 21-May- 2009.
PCT/US10/35831, file date 21-May-2010; |
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