EX-10

EX-10 2 hsto-ex10_1.htm EX-10.1 EX-10

Certain confidential portions of this exhibit were omitted by means of marking such portions with an asterisk because the identified confidential portions (i) are not material and (ii) would be competitively harmful if publicly disclosed.

JHU EXCLUSIVE LICENSE AGREEMENT CONFIDENTIAL

Exhibit 10.1

EXCLUSIVE LICENSE AGREEMENT

Johns Hopkins University and Histogen, Inc.

JHU Agreement Number A42061

This AGREEMENT is entered into by and between the Johns Hopkins University (“JHU”), a Maryland corporation having an address at 3400 N. Charles Street, Baltimore, Maryland, 21218-2695 and, Histogen, Inc. (“LICENSEE”), a Delaware corporation having an address at 10655 Sorrento Valley Road suite 200, San Diego, California 92121, and is effective on the date the last party hereto has executed this Agreement (“EFFECTIVE DATE”).

RECITALS

JHU owns, by assignment or otherwise from members of its faculty and staff, certain valuable inventions, know-how, data, material, as specified in Exhibit A-1, which JHU desires to have commercialized to make useful products and services available for the benefit of the public, including members of undeveloped countries and poor populations, as soon as possible, in accordance with JHU’s mission and purpose.

LICENSEE desires to obtain certain rights in accordance with this AGREEMENT so that it may develop, manufacture, use and/or distribute certain products and services for public use and benefit as soon as possible.

The parties agree, with the intent to be legally bound, as follows:

DEFINITIONS AND SCOPE

Capitalized terms have the meanings provided by Exhibit B or as defined in the body of this AGREEMENT.

GRANT OF LICENSES

2.1.

Grant of Exclusive Patent License. Subject to this AGREEMENT, JHU grants LICENSEE an exclusive license under the LICENSED PATENTS to make, have made, use, import, export, offer to sell and sell LICENSED PRODUCTS in the LICENSED TERRITORY and FIELD OF USE and to grant SUBLICENSES subject to the limitations provided by this AGREEMENT.

2.2.

Grant of Non-Exclusive Right to Use Data, Know-How, Materials. JHU grants LICENSEE a non-exclusive right to use the LICENSED DATA, LICENSED KNOW-HOW, or LICENSED MATERIALS existing as of the EFFECTIVE DATE of this AGREEMENT and as identified in and subject to restrictions identified in Exhibit A-1. This right to use is granted solely to LICENSEE to permit LICENSEE to develop and commercialize LICENSED PRODUCTS in the LICENSED TERRITORY in the FIELD OF USE.

2.3.

Affiliate Rights and Obligations. The LICENSED RIGHTS granted herein extend to AFFILIATES, except that AFFILIATES may not grant SUBLICENSES without JHU’s written consent. An AFFILIATE that exercises rights under this AGREEMENT shall automatically be bound by all terms and conditions of this AGREEMENT, including but not limited to indemnity and insurance provisions and

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the obligation to pay ROYALTIES. All acts or omissions by an AFFILIATE shall be considered acts or omissions of LICENSEE, which is, and shall remain, liable for them.

2.4.

Sublicense Notification. LICENSEE shall provide a complete and unredacted copy of each SUBLICENSE to JHU within y* (*) days of execution. Each SUBLICENSE shall (i) expressly reference this AGREEMENT and declare void and unenforceable against JHU any terms contrary to this AGREEMENT; (ii) prohibit sublicensing by the SUBLICENSEE; (iii) expressly incorporate the Articles (inclusive of subsections) of this AGREEMENT numbered 4, 5, 6, 7, 8, 9, 10, 11, and 12 for the benefit of JHU; and (iv) acknowledge JHU as a third party beneficiary of the SUBLICENSE having the right to audit and enforce its terms and (v) expressly require SUBLICENSEE to provide LICENSEE diligence reports on an annual basis for the express purpose of providing those SUBLICENSEE diligence reports to JHU. Failure to comply with the requirements of this Section 2.4 shall cause any purported SUBLICENSE to be void.

2.5.

Sublicenses After Termination. In addition, each SUBLICENSE shall provide for its own immediate termination or expiration upon termination or expiration of this AGREEMENT, provided that (a) SUBLICENSEE is not associated with the development or commercialization of alcohol, tobacco products or private prisons, and military armaments or on any list of prohibited individuals or entities enacted under sanctions laws (b) SUBLICENSEE requests in writing to JHU to have a direct license with JHU within * (*) days of the effective date of termination of this AGREEMENT (“INITIAL NOTICE PERIOD”), (c) SUBLICENSEE is not in breach of its SUBLICENSE as of the effective date of termination of this AGREEMENT, (d) LICENSEE has complied with JHU’s sublicense requirements under Sections 2.4 and 2.5 in the SUBLICENSE, and (e) LICENSEE has not granted a SUBLICENSE to LICENSED RIGHTS granted in this AGREEMENT for (i) no consideration or less consideration than in this AGREEMENT or (ii) in exchange for anything of value other than cash payments in consideration for a grant to LICENSED RIGHTS granted in this AGREEMENT, then SUBLICENSEE will have an automatic license to all of the rights sublicensed to it under the terms of its SUBLICENSE, provided further that JHU shall have no greater obligation to SUBLICENSEE than that which is provided for in this AGREEMENT and SUBLICENSEE shall have no greater rights or license or obligations to JHU than those provided in this AGREEMENT and in the SUBLICENSE. During the INITIAL NOTICE PERIOD, SUBLICENSEE shall be responsible for reimbursing JHU for any PATENT COSTS related to the PATENT RIGHTS, and any subsequent mutually agreed-to negotiation period, up until the effective date of the new direct license.

2.6.

Retained Research and Publication Rights. JHU retains the unrestricted right, on behalf of itself, its faculty, and staff and non-profit academic or research institutions to whom JHU extends such rights, to practice and use any LICENSED RIGHTS described in Exhibit A-1 for any research or non-profit purpose, including sponsored research and collaborations with commercial entities and assessment and treatment of patients at Johns Hopkins Health System/JHU institutions. In addition, the right of JHU’s faculty and staff to publish all information concerning what is described in Exhibit A-1 shall not be restricted by this AGREEMENT.

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2.7.

Government Rights. LICENSED PATENTS arising from research funded in whole or part by the United States government are subject to the Bayh Dole Act and its implementing regulations (35 U.S.C. §§ 200-204, 37 CFR Part 401) (collectively, “Bayh Dole Obligations”), including requirements to take effective steps in a reasonable time to achieve practical application of the LICENSED PATENTS in the FIELD OF USE and to assure LICENSED PRODUCTS sold or produced in the United States be “manufactured substantially in the United States.” LICENSEE shall comply with and cooperate with JHU in assuring compliance with the Bayh Dole Obligations. JHU’s obligations under Title 35 Sections 200-204 of the United States Code include the grant of an irrevocable, non-exclusive, nontransferable, royalty-free worldwide license to LICENSED PATENTS by JHU to the United States government, and a statement of United States government patent rights on all LICENSED PATENTS. All determinations of federal research funding involvement will be made solely by JHU, and JHU’s determination shall be honored by LICENSEE.

2.8.

Humanitarian Rights and Obligations.

2.8.1.

The parties will cooperate such that essential medicines developed under this AGREEMENT can be made available in LEAST DEVELOPED COUNTRIES. JHU agrees to consider reasonable requests of LICENSEE for a commensurate reduction of payment obligations to JHU to facilitate the availability of LICENSED PRODUCTS in such countries.

2.8.2.

JHU retains the right to grant rights to manufacture, use, distribute, sell and import the LICENSED RIGHTS described in Exhibit A-1 to a QUALIFIED HUMANITARIAN ORGANIZATION for HUMANITARIAN PURPOSES, provided that any such grant shall expressly prohibit the manufacture, use, distribution, sale or importation of any LICENSED PRODUCT in a country other than a LEAST DEVELOPED COUNTRY. Prior to granting such rights, JHU will notify LICENSEE, which shall have the first right to grant such rights to such QUALIFIED HUMANITARIAN ORGANIZATION.

2.9.

Commercial Development Sublicenses. In the event LICENSEE is unable or unwilling to develop a LICENSED PRODUCT for an unserved market, use, indication or territory, upon JHU’s request, LICENSEE shall negotiate with one or more potential sublicensees identified by JHU to sublicense the LICENSED RIGHTS to authorize development of such product. LICENSEE shall not, however, be obligated to enter into a sublicense that poses a material risk to the successful development and commercialization of LICENSED PRODUCTS by LICENSEE.

2.10.

Exclusions. Nothing in this AGREEMENT imposes obligations on JHU or grants rights in any JHU technology, intellectual property, or other assets except as expressly identified in this AGREEMENT. Except as specifically provided in this AGREEMENT, JHU does not have any obligation to provide to LICENSEE any know how, inventions, data, materials, or assistance.

DILIGENCE AND DILIGENCE REPORTS

3.1.

Milestones. LICENSEE shall achieve the MILESTONES set forth in Exhibit A-3 and

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shall notify JHU of the achievement of each MILESTONE within * (*) days of achieving them.

3.2.

Extension of Diligence Milestone. LICENSEE may request, in writing, an extension of the period for achieving a diligence MILESTONE set forth in Exhibit A-3 (each a MILESTONE) by up to * months. JHU will grant the requested extension provided LICENSEE has diligently pursued achievement of the MILESTONE. The extension of a MILESTONE shall automatically extend the deadline for subsequent MILESTONES of Exhibit A-3. LICENSEE may seek extensions for MILESTONES no more than * during the term of this AGREEMENT.

3.3.

Diligence Reports. Annually, on or before * of each year, LICENSEE shall submit a Diligence and Annual Report for the prior calendar year to JHU substantially in the form attached as Exhibit D and in sufficient detail to facilitate JHU’s compliance with its Bayh Dole Obligations.

FEES, ROYALTIES, AND MILESTONES CONSIDERATION

4.1.

Licensee’s Obligation to Pay Fees, Royalties and Other Payments. As partial consideration for the rights granted by JHU under this AGREEMENT, LICENSEE shall pay to JHU all ROYALTIES, fees, PAST PATENT COSTS, PATENT COSTS, SUBLICENSE NON-ROYALTY CONSIDERATION, and other payments LICENSED PARTIES are required to pay JHU under this AGREEMENT. SALES, actions, or omissions by any LICENSED PARTY are deemed to be SALES, actions, or omissions of LICENSEE.

4.2.

Upfront License Fee. LICENSEE shall pay to JHU a nonrefundable UPFRONT LICENSE FEE as specified in Exhibit A-2 within * (*) days of the EXECUTION DATE. The UPFRONT LICENSE FEE paid by LICENSEE to JHU shall not be credited towards any other payments LICENSEE is required to pay JHU under this AGREEMENT.

4.3.

Annual License Fee. LICENSEE shall pay to JHU annually on or before * of each calendar year the ANNUAL LICENSE FEE as specified in Exhibit A-2.

4.4.

Patent Costs. LICENSEE shall reimburse JHU for all unreimbursed PAST PATENT COSTS specified in Exhibit A-2 within * (*) days of the EXECUTION DATE. PATENT COSTS will be invoiced to LICENSEE on a rolling basis as processed by JHU or JHU’s patent counsel and are due and payable within * (*) days of receipt by LICENSEE. If agreed upon by JHU and LICENSEE, JHU shall arrange for patent counsel to bill PATENT COSTS directly to LICENSEE.

4.5.

Minimum Annual Royalty. By * of each calendar year, LICENSEE shall pay JHU the MINIMUM ANNUAL ROYALTY (“MAR”) specified in Exhibit A-2. MAR payments are non-refundable and will be credited against ROYALTIES incurred by LICENSEE for the calendar year in which the MAR was due. No MAR credits will be applied to ROYALTIES incurred in prior or subsequent calendar years.

4.6.

Royalties on Licensed Products and Reports. Within * (*) days of the end of each calendar quarter, LICENSEE shall pay ROYALTIES in accordance with Exhibit A-2 and submit the electronic Excel Quarterly SALES & ROYALTY Report set forth in

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Exhibit C. ROYALTIES shall be paid on all SALES, use or manufacture of LICENSED PRODUCTS in the LICENSED TERRITORY by all LICENSED PARTIES.

4.7.

Milestone Payments. Within * (*) days of achieving a MILESTONE, LICENSEE shall pay the related milestone payment to JHU as specified in Exhibit A-3.

4.8.

Patent Expiration and Royalty Adjustments.

4.8.1.

Expiration of Valid Claims. Upon expiration of all VALID CLAIMS, LICENSEE’s obligation shall be reduced by *%.

4.8.2.

No Royalty Stacking. Deductions for royalties or other fees due under third party licenses are not permissible under this AGREEMENT.

4.9.

Royalty Duration. LICENSEE’s obligation to pay ROYALTIES on a country-by-country basis on SALES of each LICENSED PRODUCT in such country, and shall remain in effect for the longer of (i) * years from the date of FIRST COMMERCIAL SALE in such country, or (ii) the expiration of all VALID CLAIMS in such country.

4.9.1.

International Licensed Products. The duration of the LICENSEE’s obligation to pay ROYALTIES shall be determined on a country-by-country basis from the date of FIRST COMMERCIAL SALE in a given country to the date of expiration of all VALID CLAIMS in such country.

4.10.

Sublicense Non-Royalty Consideration. LICENSEE shall pay to JHU the SUBLICENSE NON-ROYALTY CONSIDERATION as stated on Exhibit A-2 within * (*) days of receipt of SUBLICENSE NON-ROYALTY CONSIDERATION by LICENSEE.

4.11.

Assignment Fee. LICENSEE shall pay to JHU an assignment fee as provided for in Exhibit A-4 within * (*) days of receipt of assignment consideration from its assignee.

4.12.

Currency. All payments by LICENSEE to JHU shall be made in U.S. Dollars. Computation of conversion to U.S. Dollars from foreign currency transactions shall be made on a quarterly basis using the exchange rate quoted by United States Federal Reserve Bank for the last business day of the calendar quarter for which payment is due.

4.13.

Non-U.S. Taxes. LICENSEE shall pay all non-U.S. taxes imposed on all amounts payable by LICENSEE under this AGREEMENT. Such tax payments are not deductible from any payments due to JHU.

4.14.

Invoicing by JHU. Payments shall be due in accordance with this AGREEMENT regardless of whether or not invoiced by JHU. Should JHU send an invoice to LICENSEE, it may do so in electronic form via e-mail sent to the e-mail address supplied by LICENSEE from time to time and will be deemed received by LICENSEE upon transmission.

4.15.

Purchase Orders. If at any time LICENSEE requires a Purchase Order to complete payment to JHU under this AGREEMENT or a new Purchase Order number is issued on an annual basis, LICENSEE shall provide Purchase Order No. with JHU Agreement A42061 to JHTVReports@JHU.edu or other email address provided by

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JHTV. Alternatively, LICENSEE may inform JHU of need for or change in Purchase Order number on the electronic Excel Quarterly Royalty and Sales Report.

4.16.

Payment Methods. All payments to JHU shall be made either by check or wire transfer, in accordance with the payment instructions set forth in Exhibit A-2 as may be updated from time to time.

4.17.

Interest. Payments not received when due shall bear interest at the rate of * percent (*%) per annum (compounded monthly) from the date due until paid in full.

ROYALTY REPORTS AND ACCOUNTING

5.1.

Royalty Reports. Beginning with the FIRST COMMERCIAL SALE of a LICENSED PRODUCT, LICENSEE shall thereafter submit to JHU a Quarterly Sales and Royalty Report * (*) days after the end of each calendar quarter (even if there are no sales during that quarter), along with royalty payment under Section 4.6. LICENSEE agrees to submit an electronic Excel royalty report using the electronic royalty report template provided by JHU. This report will be in the form of Exhibit C and will state the number, description, and aggregate SALES of LICENSED PRODUCTS during the completed calendar quarter. All indicated columns shall be populated as they pertain to the completed calendar quarter with adjustments and unusual occurrences documented.

5.2.

Accounting and Audit Rights. Each LICENSED PARTY shall maintain complete and accurate books and records, for no less than * (*) years, relating to the rights and obligations under this AGREEMENT and any amounts payable to JHU. Such books and records shall include information sufficient to permit JHU to confirm the accuracy and completeness of any payments and reports delivered to JHU and compliance in all other respects with this AGREEMENT. Upon * days’ notice, a LICENSED PARTY shall make such books and records available for inspection by JHU or its designee during normal business hours, to verify any reports, accuracy, and completeness of payments and/or compliance with this AGREEMENT. In the event the inspections show an underpayment to JHU of *% or more for any quarter during the period examined, LICENSEE shall bear the full cost of the inspection, which shall be due and payable (along with past due ROYALTY, ROYALTY shortfall and other payment amounts plus interest per Section 4.18 from the date that such payments should have been made to JHU) within * (*) days of receiving notice from JHU of the inspection results. JHU may exercise this inspection right not more than annually unless prior inspections show consistent underpayment of *% or more (in which case JHU may conduct follow up inspections at its discretion).

5.3.

Statute of Limitations. Notwithstanding any applicable statute of limitation, LICENSEE agrees that it shall pay JHU for any underpayments revealed by an inspection for a period of * (*) years prior to the inspection.

5.4.

Final Royalty Report and Payment. Within * (*) days of termination of this AGREEMENT, each LICENSED PARTY shall submit a final written Sales and Royalty Report and pay all outstanding amounts due under this AGREEMENT.

CONFIDENTIAL INFORMATION

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6.1.

Term of Confidentiality. During the term of this AGREEMENT and for a period of two years thereafter, the parties agree that all CONFIDENTIAL INFORMATION disclosed by a party shall be maintained in confidence by the receiving party and shall not be disclosed by the receiving party to any third party unless agreed to in writing by the disclosing party or compelled by a court of competent jurisdiction; nor shall any such CONFIDENTIAL INFORMATION be used by the receiving party for any purposes other than those contemplated by this AGREEMENT.

6.2.

Standard for Confidentiality. Each party shall maintain the security of CONFIDENTIAL INFORMATION it receives from the other party by employing reasonable safeguards that are no less secure than those used to protect its own confidential records.

6.3.

Permitted Disclosures. These obligations respecting CONFIDENTIAL INFORMATION do not preclude disclosures about this AGREEMENT and amounts paid by LICENSED PARTIES as part of routinely prepared summary documents or financial reports, nor do they impede or impair JHU’s exercise of retained research and publication rights pursuant to Section 2.6. These obligations respecting CONFIDENTIAL INFORMATION do not preclude disclosures in connection with: (i) enforcing or exercising a party’s rights under this Agreement or performing a party’s obligations under this Agreement; (ii) as required by securities or other applicable laws or by the disclosure requirements of any securities exchange or other stock market on which a party’s securities are or are to be traded; and (iii) disclosure to the Affiliates, to actual or potential SUBLICENSEES, and to representatives who, in each case, have a need to know such information in order for LICENSEE to exercise its rights or fulfill its obligations under this Agreement, provided, in each case, the confidentiality of such information shall be protected by obligations minimally as required by this AGREEMENT. If either party is compelled to disclose any CONFIDENTIAL INFORMATION of the other party in response to a valid order of a court or is required by law, rule or regulation, the compelled party shall, to the extent permitted by law: (1) have made reasonable efforts to give written notice to the other party to permit it to seek a protective order or grant of confidentiality, (2) cooperate with the other party’s efforts to seek confidential or protective treatment of such information, as reasonably requested by the other party, and (3) minimize the extent of any such disclosure.

DISCLAIMERS, LIABILITY LIMITATION

7.1.

DISCLAIMER. JHU MAKES NO WARRANTIES UNDER THIS AGREEMENT. ALL TANGIBLE AND INTANGIBLE MATTER, INTELLECTUAL PROPERTY, TECHNOLOGY, RIGHTS, DATA, KNOW-HOW, AND MATERIALS (“DELIVERABLES”) LICENSED, GRANTED, OR PROVIDED BY JHU ARE “AS IS.” JHU MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, AS TO ANY MATTER INCLUDING WARRANTY OF FITNESS FOR PARTICULAR PURPOSE, MERCHANTABILITY, USEFULNESS, TITLE, NONINFRINGEMENT, VALIDITY, ENFORCEABILITY, USE, UTILITY, SCOPE, OR SUCCESFUL OPERATION OF DELIVERABLES.

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7.2.

LIMITS OF LIABILITY. SUBJECT TO LICENSEE’S INDEMNIFICATION OBLIGATION, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR INDIRECT, SPECIAL, OR CONSEQUENTIAL DAMAGES, SUCH AS LOSS OF PROFITS OR INABILITY TO USE DELIVERABLES, HOWEVER ARISING, EVEN IF IT HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. Under no circumstances shall JHU be liable for damages in excess amounts received by JHU under this AGREEMENT during the 12 months prior to the event giving rise to the claim for damages.

INDEMNITY AND INSURANCE

8.1.

Indemnification. LICENSEE and each applicable LICENSED PARTY (each an “Indemnitor” and collectively “Indemnitors”) shall protect, defend, and indemnify the JHU INDEMNITEES from and against any claims, losses, or damages of third parties (i) allegedly arising from or related in any way to any act or omission of an Indemnitor performing or exercising rights granted under this AGREEMENT, or (ii) allegedly caused by or arising in any way from LICENSED PRODUCTS. Indemnitors shall pay to defend the JHU INDEMNITIES against any claim subject to this Section 8.1 with counsel reasonably acceptable to JHU, and shall pay and/or hold the JHU INDEMNITEES harmless as against any judgments, fees, expenses, or other costs arising from or incidental to any such lawsuit, claim, demand or other action, whether or not any JHU INDEMNITEE is named as a party defendant in any such lawsuit and whether or not the JHU INDEMNITEES are alleged to be negligent or otherwise responsible for any injuries to persons or property.

8.1.1.

Exclusions. The LICENSED PARTY Indemnification obligation as stated herein excludes: (i) claims arising solely from the practice by JHU of its retained rights under Section 2.6 of this AGREEMENT; and (ii) claims arising solely from the negligent use or administration by a JHU INDEMNITEE of a LICENSED PRODUCT (but any related claim of product liability or Indemnitor negligence shall remain subject to Indemnification).

8.1.2.

Notice, Cooperation, and Participation. JHU or a JHU INDEMNITEE shall provide LICENSEE with prompt notice of any claims subject to indemnification and will provide reasonable cooperation in the investigation and defense of such claims. JHU shall have the right to participate in the defense of any claim with counsel of its choice and at its own expense. JHU shall have the right to approve any settlement against JHU or that imposes any liability or obligation on JHU.

8.2.

Insurance. LICENSEE shall, continuing throughout the term of this AGREEMENT and for a period of three years thereafter, obtain and maintain, in full force and effect and at LICENSEE’s sole cost and expense, the insurance coverage as set forth in Exhibit E. LICENSEE shall provide written proof of such insurance coverage to JHU within * days of EFFECTIVE DATE or initial coverage, whichever is later, and each renewal thereof. This AGREEMENT and the licenses granted herein shall immediately and automatically terminate in the event LICENSEE or a LICENSED PARTY (as applicable) fails to obtain the required insurance or if the insurance lapses

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or is cancelled.

8.3.

Survival. The foregoing indemnification obligations shall survive termination or expiration of this AGREEMENT and shall not be subject to any limitation of liability set forth in this AGREEMENT.

PATENTS

9.1.

Title and Authority. JHU shall retain and hold title to all patents and patent applications included in the PATENT RIGHTS. JHU retains all decision-making authority with respect to patent filing and prosecution of the PATENT RIGHTS.

9.2.

Domestic Filing and Prosecution. JHU shall have sole control over the selection of counsel, filing, prosecution, maintenance, and management of all issued patents and pending and future patent applications in the United States that are subject to this AGREEMENT. JHU, at LICENSEE’s expense, shall have the right to file, prosecute and maintain all patents and patent applications included in the PATENT RIGHTS. JHU shall request its patent counsel to timely copy LICENSEE on all official actions and written correspondence with any patent office and to afford LICENSEE an opportunity to comment on prosecution matters. LICENSEE may elect to abandon its participation in, and rights to, a patent application or issued patent filed in the United States, provided, that LICENSEE notifies JHU in writing at least * (*) days before any due date for any pending Office Action or matter or any maintenance fee due date in the case of an issued patent. Such election shall not relieve LICENSEE of the obligation to reimburse JHU for PATENT COSTS and PAST PATENT COSTS associated with such application that were incurred before JHU received actual notice of LICENSEE’s abandonment. Thereafter, JHU may file, prosecute, and/or maintain such patent applications or patents at its own expense and for its own benefit and any PATENT RIGHTS granted on such applications or patents shall be excluded from the LICENSED PATENTS. Failure to provide such notification may be considered by JHU to be LICENSEE’s authorization to proceed at LICENSEE’s expense.

9.3.

Foreign Filing and Prosecution. Upon LICENSEE’s written request and at LICENSEE’s expense, JHU will file and prosecute PATENT RIGHTS in one or more foreign jurisdiction. JHU or its designee shall have sole control over the selection of counsel, filing, prosecution, maintenance, and management of all foreign issued patents and pending and future patent applications that are subject to this AGREEMENT. Upon written notification to JHU and its patent counsel at least * (*) days in advance of any filing, response, or fee deadline, LICENSEE may elect to abandon its participation in, and rights to, a patent application filed in a foreign jurisdiction. Such election shall not relieve LICENSEE of the obligation to reimburse JHU for PATENT COSTS and PAST PATENT COSTS associated with such application that were incurred before JHU received actual notice of LICENSEE’s abandonment. Thereafter, JHU may file, prosecute, and/or maintain such foreign patent applications or patents at its own expense and for its own benefit and any PATENT RIGHTS granted on such applications or patents shall be excluded from the LICENSED PATENTS.

9.4.

Common Interest. All non-public information exchanged between JHU and the LICENSED PARTIES or their respective counsel regarding preparation, filing,

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prosecution, and maintenance of the PATENT RIGHTS shall be deemed CONFIDENTIAL INFORMATION. In addition, the parties acknowledge and agree that, with respect to such preparation, filing, prosecution and maintenance of the PATENT RIGHTS, the interests of the parties are to obtain the strongest patent protection possible, and as such, are aligned and are legal in nature. The parties agree and acknowledge that they have not waived, and nothing in this AGREEMENT constitutes a waiver of, any legal privilege concerning the PATENT RIGHTS or the CONFIDENTIAL INFORMATION, including privilege under the common interest doctrine and similar or related doctrines.

9.5.

Infringement.

9.5.1.

Notification of Infringement by third party. Each party will promptly notify the other in writing in the event it discovers, receives notice of, or otherwise reasonably suspects infringement by a third party.

9.5.2.

Suits for Infringement. LICENSEE shall have the first right, at its own expense, to initiate and prosecute an infringement action against one or more third parties to enforce the LICENSED PATENTS in the FIELD OF USE in the LICENSED TERRITORY, provided that LICENSEE: (i) notifies JHU at least * (*) days in advance of any such suit; (ii) does not file said action without the prior written consent of JHU; and (iii) carefully considers the views of JHU and the public interest in making its decision whether or not to file suit. LICENSEE: (i) shall not initiate an infringement action in the absence of a good faith belief in the infringement, validity and enforceability of the asserted claims after reasonable investigation, (ii) shall at all times keep JHU informed as to the status of the action and shall consult with JHU throughout the action; and (iii) shall at all times carefully consider the views of JHU with respect to any infringement action, including, for example, choice of litigation counsel, venue, and litigation strategy. LICENSEE shall not initiate and prosecute an infringement action if such infringement action will materially harm or impair JHU’s not for profit mission to serve the public. LICENSEE shall pay to JHU *% of any monetary award, settlement or recovery, net of all reasonable LICENSEE and JHU attorneys’ fees and out-of-pocket costs and expenses paid to third parties by LICENSEE and/or JHU in connection with each suit or settlement.

9.5.3.

JHU’s Secondary Right to Enforce. LICENSEE understands and agrees that JHU has no obligation to bring suit against third parties for infringement of the LICENSED PATENTS. In the event LICENSEE does not initiate an infringement action within * (*) days after its discovery of or receiving notification of alleged infringement, JHU may initiate and prosecute such infringement action in its sole discretion and on its own behalf. LICENSEE shall reasonably cooperate in such litigation at JHU’s request, including as a co-plaintiff, and agrees to provide any evidence, witnesses or other support of litigation as needed at its own expense. Upon initiation of an infringement action by JHU, JHU shall have the sole right to

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seek resolution of the alleged infringement through litigation, settlement agreement or otherwise. After the ninety-day period of discovery/notice has elapsed, LICENSEE shall not be permitted to transfer its rights or sublicense the LICENSED PATENTS or otherwise reach an agreement with any suspected infringer that would impact JHU’s action in any way. Any recovery from JHU’s action shall be for JHU’s sole benefit and account. All communications concerning a suit or potential suit against a third party between JHU, and LICENSEE shall be treated as CONFIDENTIAL INFORMATION and are agreed to be subject to all available privileges and protections including the joint defense privilege and common interest privilege.

9.6.

Third Party Invalidity Actions. LICENSEE shall defend at LICENSEE’s expense any declaratory judgment or other action brought by a third-party naming LICENSEE and/or JHU as a defendant and alleging invalidity of any of the PATENT RIGHTS unless such action is brought as a counterclaim to a suit against the third party initiated by JHU pursuant to JHU’s secondary right to enforce. JHU may, in its sole discretion and at its own expense, assume control of the defense of any third-party action, in which case LICENSEE shall cooperate fully with JHU in such defense at its own expense.

9.7.

Waiver of Invalidity Claims. LICENSEE, on behalf of itself, AFFILIATEs, and SUBLICENSEEs, understands and agrees that transfer of LICENSED RIGHTS under this AGREEMENT will confer substantial benefits to them, even in the absence of one of more VALID CLAIMS. Such benefits include “early mover” advantage. In addition, LICENSEE on behalf of itself, AFFILIATEs, and SUBLICENSEEs understands and agrees that the consideration paid for LICENSED RIGHTS reflects the nature and risks of early-stage technology, and the consideration required for a license to later stage technology would be significantly higher. Accordingly, each LICENSED PARTY agrees that it shall not initiate any action or proceeding to invalidate PATENT RIGHTS and hereby waives any rights they may have to do so.

9.8.

Patent Challenges. Notwithstanding the foregoing, if a LICENSED PARTY initiates an action or proceeding challenging the validity or scope of PATENT RIGHTS or that a LICENSED PRODUCT practices the PATENT RIGHTS, the following shall apply:

JHU may terminate this AGREEMENT upon written notice to LICENSEE and/or the LICENSED PARTY.

No payments or reports required by this AGREEMENT shall be suspended or delayed during any challenge to PATENT RIGHTS and no such payments shall be subject to refund or recoupment for any reason.

Not less than * (*) days prior to initiating any challenge to a PATENT RIGHTS, the party challenging PATENT RIGHTS (the “Challenging Party”) shall provide written notice of the expected challenge to JHU which shall include a clear statement of the factual and legal basis for the challenge, and an identification of all prior art, documents, products, or other matter the Challenging Party believes to provide a basis for such challenge.

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If such action or proceeding determines that at least one claim of the PATENT RIGHTS is a VALID CLAIM or practiced by a LICENSED PRODUCT, LICENSEE and the Challenging Party shall, thereafter, pay to JHU three times all payment amounts which LICENSEE and Challenging Party would otherwise be required to be paid under this AGREEMENT, other than PATENT COSTS. LICENSEE shall not be obligated to pay increased charges if it is not a party to the challenge to PATENT RIGHTS, has not assisted or facilitated the challenge, and has fully cooperated with JHU in the defense of such challenge.

9.9.

Marking. All LICENSED PRODUCTS shall be marked with the number of the applicable licensed patent(s) in accordance with each country’s patent laws.

10.

DISPUTES.

10.1.

Governing Law, Jurisdiction and Venue. This AGREEMENT shall be construed, and legal relations between the parties shall be determined, in accordance with the laws of the State of Maryland applicable to contracts executed and wholly to be performed within the State of Maryland without giving effect to the principles of conflicts of laws. Any disputes between the parties to the AGREEMENT shall be brought in the state or federal courts located in Baltimore, Maryland. Both parties hereby waive their right to a jury trial and consent to jurisdiction in such courts with respect to any disputes between them.

10.2.

Resolution. The parties shall attempt in good faith to resolve all disputes through means other than litigation, such as mediation, arbitration, or structured negotiations. Each party agrees that, prior to initiating litigation, it will confer with other party about alternatives to litigation that may enable them to resolve the dispute fairly and efficiently.

11.

TERM AND TERMINATION

11.1.

Term. The term of this AGREEMENT shall commence on the EFFECTIVE DATE and shall continue until the latter of a) date of expiration of the last to expire VALID CLAIM within the LICENSED PATENTS, b) if no patents issue, then for * (*) years from the EFFECTIVE DATE, or c) * (*) years from FIRST COMMERCIAL SALE of a LICENSED PRODUCT in the FIELD OF USE. LICENSEE shall not have any rights to make, use, sell, import, export or offer for sale any LICENSED PRODUCTS after termination (but not expiration) of this AGREEMENT under the LICENSED PATENTS or use of LICENSED DATA, LICENSED KNOW-HOW OR LICENSED MATERIALS.

11.2.

Licensee Termination for Convenience. LICENSEE may terminate this AGREEMENT upon * (*) days’ advance written notice, provided LICENSEE is meeting all of the time requirements pursuant to Article 9 of this AGREEMENT.

11.3.

JHU Termination for Cause. JHU may terminate this AGREEMENT upon * (*) days’ written notice to LICENSEE in the event of any material breach hereof, provided, that LICENSEE does not cure such breach prior to expiration of such * (*) day period. JHU may terminate this AGREEMENT immediately upon written notice to LICENSEE in the event of a material breach that is incapable of cure. A material

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breach may include:

LICENSEE’s delinquency with respect to payment or reporting.

Failure to timely achieve a MILESTONE specified in Exhibit A-3, or otherwise failing to use commercially reasonable efforts to develop, commercialize, and sell LICENSED PRODUCTS throughout the term of this AGREEMENT.

Non-compliance with record keeping or audit obligations as stated in Articles 3 and 5 of this AGREEMENT.

Voluntary bankruptcy or insolvency of LICENSEE.

Non-compliance with LICENSEE’S insurance obligations.

11.4.

Licensee Obligations Upon Termination or Expiration. Upon expiration or termination of this AGREEMENT for any reason, LICENSEE shall remit payment to JHU for all amounts due or incurred prior to the effective date of termination, and any non-cancellable expenses (such as PATENT COSTS) undertaken prior to termination.

11.5.

Effect of Termination. Upon termination of this AGREEMENT, all rights and licenses granted by JHU to LICENSEE under this AGREEMENT shall terminate and all rights in, to, and under the LICENSED RIGHTS will revert to JHU and LICENSEE shall cease using and destroy the LICENSED MATERIALS and shall provide evidence of such destruction to JHU.

12.

Miscellaneous.

12.1.

Use of Name. LICENSEE may not use the name, trademarks, logos, or trade dress of The Johns Hopkins University, The Johns Hopkins Health System, and any of their constituent parts, such as JHU, Johns Hopkins, Hopkins, the Johns Hopkins Hospital, Johns Hopkins Medicine or any contraction thereof or the name of INNOVATORS in any advertising, promotional literature, Web sites, electronic media applications, sales literature, fundraising documents, or press releases and other print or electronic communications without prior written consent from an authorized representative of JHU. Any request to make use of such names shall be made at least * (*) business days in advance of any proposed use and may be made by written request through JHTV. JHU shall have the right to list LICENSEE and display the logotype or symbol of LICENSEE on JHU’s website and on JHU publications as a licensee of JHU technology.

12.2.

Independent Parties. Nothing in this AGREEMENT shall be construed to create any agency, employment, partnership, joint venture, or similar relationship between the parties other than that of a licensor/licensee. Neither party shall have any right or authority whatsoever to incur any liability or obligation (express or implied) or otherwise act in any manner in the name or on the behalf of the other, or to make any promise, warranty, or representation binding on the other.

12.3.

Notice of Claim. Each party shall give the other party or its representative prompt notice of any suit or action filed, or of any claim made against them arising out of the performance of this AGREEMENT.

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12.4.

No Assignment. Neither party may assign this AGREEMENT, in whole or in part, without the prior written consent of the other party. Notwithstanding the foregoing, LICENSEE may assign this AGREEMENT in accordance with the terms and transfer fee requirements set forth in Exhibit A-4.

12.5.

Notices. Any notice under any of the provisions of this AGREEMENT shall be deemed given when deposited in the mail, postage prepaid, registered or certified first-class mail or by nationally-recognized private mail carrier and addressed to the applicable party at the address stated below, or such other address as such party shall specify for itself by like notice to other party. Transmission of notice by electronic mail is insufficient to meet the requirements of this provision.

If to JHU:

Executive Director

Johns Hopkins Technology Ventures

1812 Ashland Avenue, Suite 110

Baltimore, Maryland 21205

If to LICENSEE:

Steven J. Mento, PhD

President and CEO, Histogen Inc.

10655 Sorrento Valley Road suite 200,

San Diego, California 92121

With electronic copy to:

Susan A. Knudson

EVP and CFO, Histogen Inc.

LICENSEE contacts by agreement function:


Legal:	Larry Nishnick, DLA Piper
Legal:	*


Patent:	Patricia Campbell, Jones Day
Patent:	*


Licensing:	Susan A. Knudson
Licensing:	*


Billing:	Histogen Accounts Payable
Billing:	*


Insurance:	Mark Doscher (Marsh & McLennan Agency LLC)
Insurance:	*

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Reporting:	Steven J. Mento, PhD
Reporting:	*

12.6.

Export Control. Certain of the LICENSED RIGHTS may be subject to United States laws and regulations (including the Arms Export Control Act, as amended, and the Export Administration Act of 1979) controlling the export of technical data, computer software, laboratory prototypes, and other commodities. The transfer of certain technical data and commodities may require a license from the cognizant agency of the United States Government and/or written assurances that such transfers shall not be made to certain foreign countries without prior approval of such agency. LICENSEE or the applicable LICENSED PARTY shall fully comply with such export control laws. JHU makes no representation respecting the requirements for such a license, or that, if required, that such a license will be issued.

12.7.

Successors and Assigns. This AGREEMENT shall bind and inure to the benefit of the successors and permitted assigns of the parties.

12.8.

No Waivers; Severability. No waiver of any breach of any provision of this AGREEMENT shall constitute a waiver of any other breach of the same or other provision of this AGREEMENT, and no waiver shall be effective unless made in writing and signed by the party waiving. Any provision of this AGREEMENT prohibited by or unenforceable under any applicable law of any jurisdiction shall as to such jurisdiction be deemed ineffective and deleted without affecting any other provision of this AGREEMENT, which shall be interpreted so as to most fully achieve the intentions of the parties.

12.9.

Entire Agreement. This AGREEMENT supersedes all previous agreements and understandings relating to its subject matter, whether oral or in a writing, and constitutes the entire agreement of the parties and shall not be amended or altered in any respect except in a writing executed by the parties.

12.10.

No Agency. LICENSEE agrees that no representation or statement by any JHU employee shall be deemed to be a statement or representation by JHU, and that LICENSEE was not induced to enter this AGREEMENT based upon any statement or representation of JHU, or any employee of JHU. JHU is not responsible for any publications, experiments or results reported by any JHU employee prior to, or after, the EFFECTIVE DATE, including those reported by any of the INNOVATORS.

12.11.

Binding Agreement. Exchange of this AGREEMENT in draft or final form between the parties shall not be considered a binding offer, and this AGREEMENT shall not be deemed final or binding on either party until the final AGREEMENT has been signed by both parties

12.12.

Delays or Omissions. Except as expressly provided by this AGREEMENT, no delay or omission to exercise any right, power or remedy accruing to any party, shall impair any such right, power or remedy to such party nor shall it be construed to be a waiver of any such breach or default, or an acquiescence therein, or in any similar breach or default be deemed a waiver of any other prior or subsequent breach or default. Any

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waiver, permit, consent or approval of any kind or character on the part of any party of any breach or default under this AGREEMENT, or any waiver on the part of any party of any provisions or conditions of this AGREEMENT, must be in writing and shall be effective only to the extent specifically set forth in such writing. All remedies either under this AGREEMENT or by law or otherwise afforded to any party, shall be cumulative and not alternative.

12.13.

Survival. All representations, warranties, covenants, and agreements made in this AGREEMENT and which by their express terms or by implication are to be performed or continue to apply after the execution and/or termination of this AGREEMENT or are prospective in nature shall survive such expiration and/or termination. In addition, and for avoidance of doubt, the following articles shall survive any termination or expiration: Articles 5, 6, 7, 8, 9 (other than Sections 9.6–9.8), 10, 11 and 12.

12.14.

No Third-Party Beneficiaries. Nothing in this AGREEMENT shall be construed as giving any person, firm, corporation, or other entity, other than the parties and their successors and permitted assigns, any right, remedy or claim under or in respect of this AGREEMENT or any provision hereof.

12.15.

Headings. Article headings are for convenient reference and are not a part of this AGREEMENT. All referenced Exhibits are part of this AGREEMENT.

12.16.

Electronic Signature. Any signature, including any electronic symbol or process affirmatively attached to or associated with this AGREEMENT and adopted by JHU or LICENSEE to sign, authenticate, or accept such contract or record acceptance of the AGREEMENT, hereto shall have the same legal validity and enforceability as a manually executed signature or use of a paper-based recordkeeping system to the fullest extent permitted by applicable law, including the Federal Electronic Signatures in Global and National Commerce Act or any state law based on the Uniform Electronic Transactions Act, and the parties hereby waive any objection to the contrary.

[Signature Page Follows]

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in witness whereof, the parties have caused this AGREEMENT to be executed in duplicate counterparts, each of which shall be deemed to constitute an original, effective as of EFFECTIVE DATE. The undersigned verify that they have the authority to bind to this AGREEMENT the party on behalf of which they are executing.

This AGREEMENT includes the following Exhibits:

Exhibit A: Financial Terms

Exhibit A-1: LICENSED RIGHTS, FIELD OF USE, and LICENSED TERRITORY

Exhibit A-2: PATENT COSTS, Fees, ROYALTIES, and Payment Terms
Exhibit A-3: MILESTONES

Exhibit A-4: Permitted Assignment

Exhibit B: Definition of Terms

Exhibit C. Quarterly Sales & Royalty Report Form

Exhibit D: Diligence and Annual Report Form

Exhibit E: Insurance


Johns Hopkins University	Histogen, Inc.
By: [j/s/ Steven L. KousourisHTVSignerSignature_BSXc5Ny]	By: /s/ Steven J. Mento, Ph.D. [counterpartySignerSignature_9qaslG3]
Name: [Steven L. KousourisjHTVSignerName_aPJQaSV]	Name: Steven J. Mento, Ph.D. [counterpartySignerName_CQGTGjH]
Title: [jHExecutive Director, Technology TransferTVSignerTitle_TUFaYbq]	Title: President and Chief Executive Officer[counterpartySignerTitle_kQtWTNq]
Date: [jHApril 2, 2023TVSignerDateField_rDX41Xr]	Date: April 3, 2023[counterpartySignerDateField_Dj10fDN]

[agreementManagerInitialsSignature_1ApiSME]

[workflowOwnerInitialsSignature_30ywvUc]

[directorInitialsSignature_KRBzN9V]

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Exhibit A (A-1, A-2, A-3, A-4, A-5)

Exhibit A-1: LICENSED RIGHTS, FIELD OF USE, and LICENSED TERRITORY


JHU TECH ID	* entitled “Caspase inhibition as a host-directed immunotherapy against bacterial infections”
INNOVATORS	(a) * (b) * (c) * (d) *
LICENSED PATENTS	*
LICENSED KNOW-HOW	*
LICENSED DATA	*
LICENSED MATERIAL	*
FIELD OF USE	The use of Emricasan as an active pharmaceutical ingredient for the treatment, prophylaxis, or amelioration of any condition, disease, or disorder in humans resulting from viral or bacterial infections (including but not limited to, MRSA, VRSA, and SARS-CoV-2).
LICENSED TERRITORY	Worldwide

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Exhibit A-2

PATENT COSTS, Fees, ROYALTIES, and Payment Terms


UPFRONT LICENSE FEE	Fifty thousand ($ *) dollars due within thirty (30) days of the License Agreement EFFECTIVE DATE
PAST PATENT COSTS	$* (PAST PATENT COSTS for matters prior September 14, 2022) For clarity, PATENT COSTS incurred after September 15, 2022 are covered by Section 5.1.
MINIMUM ANNUAL ROYALTY (“MAR”)	Due by January 1 of each calendar year: 1st year: $ * due 1/1/2024 2nd year: $ * due 1/1/2025 3rd year: $ * due 1/1/2026 4th year: $ * due 1/1/2027 5th year: $ * due 1/1/2028 6th year: $ * due 1/1/2029 7th year: $ * due 1/1/2030 8th year: $ * due 1/1/2031 9th year: $ * due 1/1/2032 10th year etc. $ * due 1/1/2033
ROYALTY	* (*%) percent of NET SALES REVENUE on LICENSED PRODUCT in the FIELD OF USE. For clarity, pursuant to Section 4.8.2, ROYALTY is not subject to stacking.
SUBLICENSE NON-ROYALTY CONSIDERATION	* (*%) percent of all consideration received by LICENSEE from a SUBLICENSEE in exchange for grant of SUBLICENSE rights under this AGREEMENT, but excluding (i) any consideration received by LICENSEE for ROYALTIES on SUBLICENSEE SALES (ROYALTIES on SALES by SUBLICENSEES will be treated as if LICENSEE made the SALE), (ii) any reimbursement of development costs (specifically stated in the SUBLICENSE) received by LICENSEE from SUBLICENSEE, (iii) any payment of PAST PATENT COSTS or PATENT COSTS made by SUBLICENSEE to LICENSEE, and (iv) any consideration received by LICENSEE for the sale of debt or equity securities in connection with the grant of a SUBLICENSE.

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Payment Instructions

Checks are to be made payable to the “Johns Hopkins University.”

All check payments from LICENSEE to JHU shall be sent to:

or such other addresses which JHU may designate in writing from time to time.

Wire transfers may be made through:

DOMESTIC ACH & WIRE

INTERNATIONAL FED WIRE

LICENSEE shall be responsible for any, and all costs associated with wire transfers.

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Exhibit A-3

MILESTONES


Date or Deadline	Description of Diligence Milestone	Milestone Fee
*	*	$ *
*	*	$ *
*	*	$ *
*	*	$ *
*	*	$ *
*	*	$ *
	*	$ *

MILESTONE payment fees set forth in the above table shall be payable within thirty (30) days of LICENSED PRODUCT achieving such MILESTONE and MILESTONE payment fees shall be due at *% of the amounts set forth in the table above, within (30) days of each additional indication after the first indication to meet such MILESTONE.

In the event that a Phase II clinical trial for LICENSED PRODUCT is conducted at JHU, LICENSEE is excused from making the accrued related MILESTONE payments to JHU until the MILESTONE for Phase III clinical trial is met. Under such circumstances, LICENSEE agrees that it will pay the applicable previously unpaid Phase II MILESTONE payments when it delivers the Phase III MILESTONE payment to JHU. Further, in the event that a Phase II and/or Phase III clinical trial is not required for market approval, LICENSEE agrees that it will pay the accrued Phase II and/or Phase III MILESTONE payment fees otherwise due under Phase II through Phase III MILESTONES when it submits MILESTONE payment fee to JHU for market approval.

The MILESTONES described above shall be deemed achieved if the objectives are met by LICENSEE or any SUBLICENSEE. Any amounts payable by LICENSEE hereunder may be assigned to, and payable by, a SUBLICENSEE.

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Exhibit A-4

Permitted Assignment

LICENSEE may assign this AGREEMENT as part of a sale or merger of substantially all of LICENSEE’s business or assets, regardless of whether such a sale occurs through an asset sale, stock sale, merger or other combination, provided:

(a) LICENSEE provides written notice to JHU at least *(*) days in advance of such assignment;

(b) The assignee agrees, in a writing delivered to JHU, to be bound by all provisions of this AGREEMENT; and

(c) LICENSEE remits an assignment fee to JHU for the first Permitted Assignment equal to the greater of (i) twice the MAR applicable to the year when the assignment will be completed; or (ii) $ *. For any subsequent Permitted Assignments, LICENSEE shall remit an assignment fee to JHU equal to the lesser of (i) twice the MAR applicable to the year when the assignment will be completed; or (ii) $ *.

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Exhibit B

Definitions

“AFFILIATE” means any corporation, licensee, partnership, joint venture, or other entity, which controls, is controlled by or is under common control with LICENSEE, as evidenced by the direct or indirect ownership of at least 50% of voting rights governing the entity or the contractual power to control such rights.

“COMBINATION PRODUCT” means a collection or group of products sold together (such as in a kit or package) that contains (i) a LICENSED PRODUCT and (ii) one or more other functional products (“Other Products”) that has been sold separately for use without the LICENSED PRODUCT and which is not essential to the use or practice of the LICENSED PRODUCT. For example, a diagnostic panel comprising a LICENSED PRODUCT and an independent diagnostic biomarker.

“COMPLETION” of a clinical trial milestone means first public release of TOP-LINE DATA.

“CONFIDENTIAL INFORMATION” means information disclosed by a party (the “Disclosing Party”) to the other party (the “Receiving Party”) in connection with performance of this AGREEMENT that (i) concerns the LICENSED RIGHTS and has been maintained by the Disclosing Party as nonpublic or proprietary information, and (ii) is marked Confidential or otherwise expressly designated as Confidential. To be deemed CONFIDENTIAL INFORMATION, oral disclosures must (i) concern the LICENSED RIGHTS, have been maintained by the Disclosing Party as nonpublic or proprietary information, and be described in writing as confidential by the Disclosing Party within fourteen (14) days of disclosure to the Receiving Party. CONFIDENTIAL INFORMATION does not include information that (a) was already in the Receiving Party’s possession before the disclosure by the Disclosing Party; (b) has been published or is later published unless such publication is a breach of this AGREEMENT; (c) is received by the Receiving Party from a third party not under an obligation of confidentiality; or (d) is independently developed by the Receiving Party’s employees who did not have access to CONFIDENTIAL INFORMATION.

“DISCOVERED PRODUCT” means a product, material, or service that is identified, selected, or determined to have utility in whole or in part by the use of a LICENSED PRODUCT, including the use of a screening method or assay covered by the LICENSED RIGHTS.

“EXECUTION DATE” means the date that the last party to sign executes this AGREEMENT.

“FIELD OF USE” is defined in Exhibit A-1.

“FIRST COMMERCIAL SALE" means the first transfer by a LICENSEE for value of a LICENSED PRODUCT, with the exemption of materials transferred for use in a clinical trial at a nominal cost to the recipient.

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“HUMANITARIAN PURPOSE” means practice of LICENSED RIGHTS in the prevention or treatment of disease in humans by or on behalf of any QUALIFIED HUMANITARIAN ORGANIZATION (including, for clarity, practice of LICENSED RIGHTS by contractors, manufactures or distributors acting for or on behalf of such QUALIFIED HUMANITARIAN ORGANIZATIONs on a fee-for-service, fee-for-product or charitable basis): (i) to manufacture LICENSED PRODUCTS anywhere in the world for the sole and express purposes of distribution and use of such LICENSED PRODUCTS in one or more LEAST DEVELOPED COUNTRIES, and (ii) to sell or otherwise distribute LICENSED PRODUCTS for use solely in one or more LEAST DEVELOPED COUNTRIES; provided, however, that sales and distribution of LICENSED PRODUCTS shall not be deemed made for humanitarian purposes unless products are distributed at locally-affordable prices.

“INNOVATORS” means the individuals who invented, authored, or created the LICENSED RIGHTS as identified in in Exhibit A-1.

“JHU INDEMNITEES” means JHU, The Johns Hopkins Hospital, The Johns Hopkins Health System Corporation, and their affiliated entities, their present and former trustees, officers, INNOVATORS, agents, faculty, employees, and students.

“LEAST DEVELOPED COUNTRY” means those jurisdictions so defined by the United Nations Country Classification in the most recent United Nations’ publication “Statistical Annex.”

“LICENSED DATA” means the data specified in Exhibit A-1 that exists as of the EFFECTIVE DATE of this AGREEMENT.

“LICENSED KNOW-HOW” means the know-how described in Exhibit A-1 that exists as of the EFFECTIVE DATE of this AGREEMENT.

“LICENSED MATERIAL” means the material described in Exhibit A-1 that exists as of the EFFECTIVE DATE of this AGREEMENT.

“LICENSED PARTIES” means LICENSEE, AFFILIATE, and/or SUBLICENSEE (as applicable).

“LICENSED PATENTS” shall mean any patent or patent application listed in Exhibit A of the definitive agreement, including any renewals, divisions, continuations , or requests for continued examination of such patent applications, and all patents or certificates of invention issuing thereon, and any and all reissues, reexaminations, extensions, supplementary protection certificates, divisions, renewals, substitutions, confirmations, registrations, revalidations, revisions, and additions of or to any of the foregoing, anywhere in the world For clarity, Patents excludes the claims of any continuation-in-part (CIP) patent application or patent, unless (a) such CIP contains only the Inventors, (b) all such claims in such CIP are entirely supported in the applications listed in Exhibit A, and (c) such claims are entitled to the priority date of an application listed in Exhibit A.

“LICENSED PRODUCT” means any service, process, method, material, compositions, drug, or other product that (i) comprises, constitutes, or embodies the LICENSED RIGHTS, or (ii) requires use or practice of the LICENSED RIGHTS by LICENSED PARTIES or their customers.

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“LICENSED RIGHTS” means all rights respecting LICENSED PATENTS, LICENSED DATA, LICENSED KNOW-HOW, and LICENSED MATERIALS granted to LICENSEE in Article 2 of this AGREEMENT.

“LICENSED TERRITORY” means the territory specified in Exhibit A-1.

“MILESTONE” means a diligence milestone or event specified in Exhibit A-3.

“NET SALES REVENUE” means and includes the gross value of everything of value received by LICENSED PARTIES as consideration for the SALE of LICENSED PRODUCTS or COMBINATION PRODUCTS, including the fair market value of equity, intangible rights, services, and other things of value realized from SALES except for SUBLICENSEE NON-ROYALTY CONSIDERATION, as that term is defined in Exhibit A-2 of this AGREEMENT.

NET SALES REVENUE generated from COMBINATION PRODUCTS shall be determined with the formula: COMBINATION PRODUCT NET SALES REVENUE = NET SALES REVENUE *C/(C+D), where C is the total gross invoice price of the LICENSED PRODUCT when sold separately and D is the total gross invoice price of the Other Product(s) when sold separately.

NET SALES REVENUE excludes the following items, provided they are separately invoiced to and paid by a purchaser of LICENSED PRODUCTS and thereafter paid or remitted by LICENSEE:

•

import, export, excise and sales taxes, and custom duties;

•

shipping charges and transportation from the place of manufacture to the customer's premises or point of installation;

•

trade discounts, including trade, cash and quantity discounts or rebates, credits or refunds actually granted by a LICENSED PARTY;

•

allowances or credits actually granted upon claims, returns or rejections of products, including recalls, regardless of the party requesting such recall;

•

rebates and chargebacks actually granted by a LICENSED PARTY or retroactive price reductions made to federal, state or local governments (or their agencies), or any third party payor, administrator or contractor, including managed health organizations; and

•

payments required by law to be made under Medicaid, Medicare or other government special medical assistance programs (including, but not limited to, fees due under the United States Patient Protection and Affordable Care Act of 2010 (Pub. L. No. 111-148, as may be amended)), specific to LICENSED PRODUCT or allocable to LICENSED PRODUCT).

“PATENT COSTS” means all costs of prosecuting and maintaining any LICENSED PATENT, including reasonable attorneys’ fees and expenses, and fees for patent filing(s), maintenance, annuities, translation, and defense against claims of infringement or invalidity, including fees and costs incurred in administrative proceedings or disputes pursuant to the America Invents Act of 2011 (such as an Inter Partes Review, Post Grant Review or

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Derivation Proceedings before the U.S. Patent Trial and Appeal Board), incurred by JHU. PATENT COSTS excludes PAST PATENT COSTS.

“PAST PATENT COSTS” means all PATENT COSTS that are incurred by JHU prior to the EXECUTION DATE of this AGREEMENT and are able to be billed to LICENSEE on the EXECUTION DATE. For the avoidance of doubt, those PATENT COSTS incurred before the EXECUTION DATE but not available for billing until after the EXECUTION DATE will be billed as PATENT COSTS.

“PATENT RIGHTS” means the rights granted to LICENSEE in respect of the LICENSED PATENTS (and subject to the rights reserved or maintained by JHU).

“QUALIFIED HUMANITARIAN ORGANIZATION” means any governmental agency, non-governmental agency or other not-for-profit organization that has as one of its bona fide missions to address the public health needs of underserved populations on a not-for-profit basis. For clarity, QUALIFIED HUMANITARIAN ORGANIZATIONS do not include non-governmental agencies and not-for-profit organizations that are formed or established for the benefit of any for-profit entity.

“ROYALTIES” means payments owed to JHU in consideration of the rights granted to LICENSED PARTIES under this AGREEMENT that are determined as a percentage of NET SALES REVENUE as explicitly set forth in Exhibit A-2 of this AGREEMENT.

“SALE” means a sale, license, lease, performance, transfer, delivery, contract to provide, or other disposition or conveyance for value of a LICENSED PRODUCT.

“SUBLICENSE” means an agreement in which LICENSEE (i) grants or otherwise transfers any of the LICENSED RIGHTS, (ii) agrees not to assert or seek a legal remedy for the practice of LICENSED RIGHTS, or (iii) creates an obligation to grant, assign or transfer any LICENSED RIGHTS to any other entity (other than an AFFILIATE).

“SUBLICENSEE” means any person or entity to which LICENSEE has granted a SUBLICENSE under this AGREEMENT.

“SUBLICENSE NON-ROYALTY CONSIDERATION” is defined in Exhibit A-2 of this AGREEMENT.

“TOP-LINE DATA” means, with respect to a clinical study, a summary of patient demographic data, data for the primary endpoint, and safety data derived from the unblinded, locked clinical trial database.

“VALID CLAIM” means any issued or pending claim of an unexpired, unabandoned, LICENSED PATENT that (a) has not been conclusively revoked or declared unenforceable, unpatentable or invalid by a competent court or tribunal and which is unappealable or unappealed in the time allowed for appeal, and which has not been cancelled, withdrawn or abandoned or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise, and (b) with respect to claims of a pending patent application, such patent application has not been pending for more than * (*) years from its earliest claimed priority date.

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Exhibit C

Quarterly Sales and Royalty Report

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Exhibit D

Diligence and Annual Report

LICENSEE Name: __________________________________________________

JHU Agreement Number: __ *____________________________________

JHU Reference Number(s) *, _______, ________, _______,

Reporting Period: From ______________ To ______________

Please provide the following information in a separate document:

A description of progress by LICENSED PARTIES toward commercialization of LICENSED PRODUCTS, including work completed, key scientific discoveries, summary of work-in-progress, current schedule of anticipated events or MILESTONES, market plans (if any), significant corporate transactions and documents sufficient to evidence each.

A description and documentation of all FDA or other governmental filings and/or approvals regarding any LICENSED PRODUCT or LICENSED RIGHTS.

Certificate of Insurance or other evidence of insurance

_______ is attached

Identification of all LICENSED PARTIES (AFFILIATE and SUBLICENSEE):

________ NONE
________ List attached with description of rights exercised.

SUBLICENSE(s) entered during the year:

______ NONE
(copy of each SUBLICENSE attached)

A description of any Material Event (e.g., change of control, name change, or other significant change related to this AGREEMENT or LICENSEE:

________ NONE

Details:

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Economic Development:

Number of Current Employees:

Full-time:

Part-time:

Interns:

Consultants:

Revenue for the immediately preceding * (*) month period:

Funding (copy and complete for each funding/investment received during the reporting period):

Funding Source:

Funding Type (Debt, Venture or Other):

Funding Amount:

Funding Date:

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SEND DILIGENCE AND ANNUAL REPORT AND QUARTERLY SALES AND ROYALTY REPORT TO:

Via mail or private mail carrier: Via email (Preferred):


Licensee Reporting Group		JHTVReports@JHU.EDU Expect Auto-Reply
Johns Hopkins Technology Ventures The Johns Hopkins University 1812 Ashland Avenue, Suite 110 Baltimore, MD 21205 Telephone for overnight courier: 410-614-0300		No Auto-Reply? Contact: Marlene Moore at *
Interested in reporting via our Licensee Reporting Portal? To request details about this reporting option.		Contact us at JHTVReports@JHU.edu

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Exhibit E

Required Insurance Coverages

Assumption of Liability. LICENSEE hereby assumes full liability for any, and all lawsuits, claims, demands, judgments, costs, fees (including attorney’s fees), expenses, injuries or losses arising from or relating to the LICENSED PRODUCTS.

Insurance. LICENSEE will obtain and maintain Comprehensive General Liability Insurance with a reputable and financially secure insurance carrier acceptable to JHU. Prior to initial human testing or FIRST COMMERCIAL SALE of any LICENSED PRODUCT, LICENSEE will obtain and maintain in addition to the Comprehensive General Liability Insurance, Product Liability Insurance with a reputable and financially secure insurance carrier acceptable to JHU, to cover any liability arising from or relating to the LICENSED PRODUCTS. The insurance policy shall provide minimum coverage in the amounts and subject to the provisions below.

General. LICENSEE shall obtain and maintain, in full force and effect and at LICENSEE’s sole cost and expense insurance policies providing:

Commercial general liability insurance (including coverage and any necessary endorsements for products /completed operations as well as for clinical trials if any such trials are to be performed by or on behalf of LICENSEE) which provides, for each annual policy period, coverage of no less than the minimum limits specified below for injury, death and property damage resulting from each occurrence during the policy period; and

If required by law, worker’s compensation insurance.

Initial Policy Limits. The commercial general liability and products liability coverages shall have the following minimum limits:

Commercial general liability: one million dollars ($ *) each occurrence, two million dollars ($*) general aggregate. LICENSEE shall have thirty (30) days following the EXECUTION DATE to obtain such coverage.

Products liability: From the date immediately prior to initial human testing or first Commercial SALE: $ *per claim and $ *in the aggregate.

JHU may periodically evaluate the adequacy of the minimum coverage of insurance and coverage limits specified in this AGREEMENT. JHU reserves the right to require LICENSEE to adjust the insurance coverage by modifying the types of required coverages, the limits and/or financial rating and/or the method of financial rating of LICENSEE’s insurers as such changes are required of JHU by its insurance carrier. JHU shall provide LICENSEE with reasonable notice, contingent on JHU receiving timely notice from its insurance carrier, of any proposed modification, and, if so, requested by LICENSEE, discuss any proposed modifications in good faith.

Policy Requirements. Each policy of insurance required by this AGREEMENT shall:

be issued by reputable and financially secure insurance carriers having at least an A- rating (A- rating or above by A.M. Best) and an A.M. Best Class Size of at least VIII,

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list each of JHU, its trustees, officers, employees, faculty, staff, students, agents, and their successors, heirs and assigns as additional insureds,

be endorsed to provide that the insurer waives all subrogation rights it has or may have against any additional insured, and

be primary in respect of all additional insureds.

Evidence of Insurance. LICENSEE shall provide JHU with a Certificate of Insurance from each such insurer which evidences compliance by LICENSEE with its obligations under this AGREEMENT. Upon the request of JHU, LICENSEE shall provide JHU with a copy of the policy, status of claims and claims history respecting any of the insurance required to be maintained by LICENSEE under this AGREEMENT. Further, LICENSEE will not cancel or fail to renew the identified insurance without giving JHU at least thirty (30) days’ prior written notice of such cancellation.

Primary Coverage. All insurance of LICENSEE will be primary coverage; other insurance of JHU and JHU Indemnities will be excess and noncontributory.

Clarifications. For the avoidance of doubt, the minimum insurance coverage and limits set forth in this AGREEMENT do not constitute a limitation on LICENSEE’s liability or obligations to indemnify or defend JHU and the JHU INDEMNITEES and any other

additional insured under this AGREEMENT.

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