UNIVERSITY OF MIAMI EXCLUSIVE LICENSE AGREEMENT
Exhibit 10.2
[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
This Exclusive License Agreement (this “Agreement”) is entered into and made effective as of the last dated signature below (the “Effective Date”) between University of Miami, a Florida not-for-profit corporation, having business offices at 0000 XX 0xx Xxxxxx, (X000), Xxxxx, Xxxxxxx 00000 (“UNIVERSITY”), on behalf of itself, Emory and MGH (as defined below), and Orphazyme ApS, CVR no. DK 3226 6355, a for-profit corporation organized under the laws of Denmark, having business offices at Ole Xxxxxxx Xxx 0, XX-0000 Xxxxxxxxxx N, Denmark (“LICENSEE”). For purposes of this Agreement, each of UNIVERSITY and LICENSEE may be individually referred to as a “Party” and collectively referred to as the “Parties.”
Certain Technology and Know-How (as defined below) was developed during research conducted by investigators at the UNIVERSITY, Emory University (“Emory”), and The General Hospital Corporation, d/b/a Massachusetts General Hospital (“MGH”), collectively the “Institutions”. Xx. Xxxxxxx Xxxxxxx currently at UNIVERSITY and formerly at Emory, in collaboration with Drs. Merit Cudknowicz, Xxxxx Xxxxxx, and Xxxxx Xxxxxxxxxx at MGH have developed certain Technology and Know-How described in Appendix A. Each of the investigators have assigned the Technology and Know-How licensed hereunder to their respective Institution in accordance with their Institution’s Intellectual Property policy, including all right and title to certain inventions as described in the investigators’ invention disclosure documents attached as Appendix A.
The Technology and Know-How is jointly owned by the Institutions. Pursuant to a certain Three-Way Inter-Institutional Agreement (the “Three-Way Inter-Institutional Agreement”) effective on March 5, 2019 and executed between the Institutions, Emory and MGH have granted the UNIVERSITY the exclusive right to negotiate and administer an exclusive license to each of Emory’s and MGH’s rights in the Technology and Know-How being licensed to LICENSOR hereto.
Each of the Institutions want to have the Technology and Know-How perfected and marketed as soon as possible so that resulting products may be available for public use and benefit. LICENSEE wants to acquire an exclusive license to the Technology and Know-How for the purposes of exploiting Licensed Products and Licensed Processes and practicing the invention(s) disclosed, in the Territory and in the Field of Use as set forth and defined below.
1. |
1.1 | “Affiliate” shall mean any corporation or other business entity controlled by, controlling or under common control with UNIVERSITY or LICENSEE. For this purpose, “control” shall mean direct or indirect beneficial ownership of at least a fifty percent (50%) of the equity interests of, or at least a fifty percent (50%) interest in the income of such corporation or other business entity, or any business entity that is more than fifty percent (50%) owned by a business entity that owns more than fifty percent (50%) of LICENSEE, or such other relationship as in fact, constitutes actual control. |
1
1.2 | “Amyotrophic Lateral Sclerosis” shall mean amyotrophic lateral sclerosis (ALS), as broadly defined, to include patients with mixed upper motor neuron (UMN) and lower motor neuron (LMN) pathology (classic ALS), primarily LMN disease (LMN-predominant ALS and progressive muscular atrophy) and primarily UMN disease (UMN-predominant ALS and primary lateral sclerosis). |
1.3 | “Arimoclomol” shall mean Arimoclomol or any derivative of Arimoclomol exhibiting the same biological activity and for which the data generated under the Study is used to support an application to the FDA or similar regulatory authority in order to gain Regulatory Approval. |
1.4 | “Control” shall mean, with respect to any intellectual property right, the possession of the right (whether by ownership, license or otherwise (other than pursuant to a license granted under this Agreement)), to assign, or grant a license, sublicense or other right to or under, such intellectual property right as provided for herein without violating the terms of any agreement or other arrangement with any third party. |
1.5 | “Excluded Entity” shall mean any corporation, business entity or person (i) associated with the development or commercialization of alcohol, tobacco products or private prisons, military armaments and pornography or (ii) on any list of prohibited individuals or entities enacted under United States economic sanctions and anti-boycott laws. |
1.6 | “Field of Use” shall mean any and all uses or applications of Institutions’ intellectual property titled “Arimoclomol for SOD1 ALS” with University’s reference number identified as UMIP- 138, Emory’s reference number identified as 08029 and MGH’s reference number identified as 25521. |
1.7 | “Indication” means any human disease, condition or syndrome, or sign or symptom of, or associated with, a human disease, condition or syndrome in a particular target patient population. |
1.8 | “Inventors” shall mean Xx. Xxxxxxx Xxxxxxx during the term of his employment at UNIVERSITY and Emory, in addition to Drs. Merit Cudknowicz and Xxxxx Xxxxxx during the term of their respective employments at MGH. |
1.9 | “Know-How” shall mean all (a) information, techniques, technology, practices, trade secrets, inventions (whether patentable or not), methods, knowledge, skill, experience, data, results (including pharmacological, toxicological and clinical test data and results, chemical structures, sequences, processes, formulae, techniques, research data, reports, standard operating procedures and batch records), analytical and quality control data, analytical methods (including applicable reference standards), full batch documentation, packaging records, release, stability, storage and shelf-life data, and manufacturing process information, results or descriptions, software and algorithms of each of the Institutions; and (b) tangible manifestations thereof. As used in this Agreement, “clinical test data” shall include all information related to clinical or non-clinical testing, including patient report forms, investigators’ reports, biostatistical, pharmaco-economic and other related analyses, regulatory filings and communications, de-identified of any individually identifiable health information, including any data that contains one or more of the identifiers listed in §164.514(b)(2) and in compliance with any federal and state privacy laws, including the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”). The Parties understand and agree that this Agreement will not include any patient data for commercial use which has not been de-identified as contemplated above. |
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[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
1.10 | “Licensed Product” shall mean any pharmaceutical product containing Arimoclomol, which is made, developed, used or sold by LICENSEE or an Affiliate or Sublicensee of LICENSEE for which the applicable Indication is intended to receive Regulatory Approval with a product label specifying the treatment of patients with Amyotrophic Lateral Sclerosis (the “Approved ALS Indication”); and is intended to be the subject of a Regulatory Approval filing for the Approved ALS Indication which includes the clinical test data and results from the Study. |
1.11 | “Licensed Process” shall mean, solely for Arimoclomol, any process or part thereof made, developed, used or sold by LICENSEE or an Affiliate or Sublicensee of LICENSEE which incorporates or uses the Technology. |
1.12 | “Net Sales” shall be calculated as set forth in this section, and shall mean gross amounts invoiced by LICENSEE and/or its Affiliates and/or Sublicensees on commercial sales of Licensed Products or use of Licensed Processes after Regulatory Approval, if applicable, thereof to third parties (excluding Sublicensees and Affiliates), less deductions for the following, determined in accordance with generally accepted accounting principles, consistently and strictly applied: |
a. | sales and excise taxes (including annual fees due under Section 9008 of the United States Patient Protection and Affordable Care Act of 2010 (Pub. L. No. 111-48) and other comparable Laws as and to the extent applicable), value added taxes, and duties which fall due and are paid by the purchaser as a direct consequence of such sales and any other governmental charges imposed upon the importation, use or sale of Licensed Products or Licensed Processes, but only to the extent that such taxes and duties are actually included and itemized in the gross sales amounts invoiced to and specifically paid by the purchaser over and above the price of the Licensed Products or Licensed Processes; |
b. | trade, quantity and cash discounts actually allowed and taken; |
c. | allowances or credits to customers on account of shelf adjustments, failure to supply, rejection, withdrawal, recall or return of Licensed Products or on account of retroactive price reductions affecting Licensed Products, to the extent that such allowances or credits are actually allowed and taken; |
d. | any charges for freight, postage, shipping or transportation or for shipping insurance; |
e. | rebates and charge backs specifically related to Licensed Products or Licensed Processes on an actual credited or paid basis, including those granted to government agencies and group purchasing and managed care organizations and entities (such rebates and charge backs to be accrued as an estimate in the month in which the related Licensed Products or Licensed Processes are sold by using generally accepted accounting principles) to the extent that such rebates and charge backs are actually allowed and taken; |
f. | sales contract administrative fees, fees paid to distributors, wholesaler fees or service charges and other payments to customers in connection with the sale of Licensed Products or Licensed Processes for any non-separable services, to the extent actually allowed and taken; and |
If a Licensed Product is a Combination Product (as defined below), the Net Sales for such Combination Product in each country or jurisdiction shall be calculated as follows:
(i) If LICENSEE or any of its Affiliates or Sublicensees separately sells in such country or other jurisdiction, (A) a product containing as its sole active ingredient Arimoclomol contained in such Combination Product (the “Mono Product”) and (B) products containing as their sole active ingredients the other active ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying actual Net Sales of such Combination Product by the fraction A/(A+B) where: “A” is LICENSEE’s (or its Affiliate’s or Sublicensee’s, as applicable) average Net Sales price
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[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction and “B” is LICENSEE’s (or its Affiliate’s or Sublicensee’s, as applicable) average net sales price (determined in the same manner as “Net Sales”) during the period to which the Net Sales calculation applies in such country or other jurisdiction, for products that contain as their sole active ingredients the other active ingredients in such Combination Product.
(ii) If LICENSEE or any of its Affiliates or Sublicensees separately sells in such country or other jurisdiction the Mono Product but does not separately sell in such country or other jurisdiction products containing as their sole active ingredients the other active ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction A/C where: “A” is LICENSEE’s (or its Affiliate’s or Sublicensee’s, as applicable) average Net Sales price during the period to which the Net Sales calculation applies for the Mono Product in such country or other jurisdiction, and “C” is LICENSEE’s (or its Affiliate’s or Sublicensee’s, as applicable) average Net Sales price in such country or other jurisdiction during the period to which the Net Sales calculation applies for such Combination Product.
(iii) If LICENSEE and its Affiliates and Sublicensees do not separately sell in such country or other jurisdiction the Mono Product but do separately sell products containing as their sole active ingredients the other active ingredients contained in such Combination Product, the Net Sales attributable to such Combination Product shall be calculated by multiplying the Net Sales of such Combination Product by the fraction (D-E)/D where: “D” is the average Net Sales price during the period to which the Net Sales calculation applies for such Combination Product in such country or other jurisdiction and “E” is the average net sales price (determined in the same manner as “Net Sales”) during the period to which the Net Sales calculation applies for products that contain as their sole active ingredients the other active ingredients in such Combination Product.
(iv) If LICENSEE and its Affiliates and Sublicensees do not separately sell in such country or other jurisdiction both the Mono Product and the other active ingredient or ingredients in such Combination Product, the Net Sales attributable to such Combination Product shall be determined by the Parties in good faith based on the relative fair market value of such Mono Product and such other active ingredient or ingredients. If the Parties cannot agree on such relative value, the Dispute shall be resolved pursuant to Section 14.4. Net Sales of a Licensed Product shall only include sales of the Licensed Product containing Arimoclomol, and not any other compound (other than a compound that is sold as a fixed-dosed combination or co-packed with Arimoclomol) or therapy that may be used in combination with such Licensed Product.
As used in this definition of “Net Sales,” “Combination Product” means any Licensed Product sold together (whether or not as part of a kit) with any other active pharmaceutical ingredient or medical device or component thereof.
1.13 | “Regulatory Approval” means the approval, license or authorization of the U.S. Food and Drug Administration (“FDA”) or similar regulatory body in another country or region necessary for the marketing and sale of a product for a particular Indication in the United States, the European Union, Japan, Brazil, Australia, New Zealand, China, Mexico, Korea, Canada, the United Kingdom, and India. |
1.14 | “Study” shall mean the Arimoclomol clinical trial (XxxxxxxxXxxxxx.xxx Identifier: NCT00706147; entitled: Phase II/III Randomized, Placebo-controlled Trial of Arimoclomol in SOD1 Positive Familial Amyotrophic Lateral Sclerosis), which includes the study referred to in the definition of “Licensed Technology” in the Three-Way Inter-Institutional Agreement. |
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[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
1.15 | “Sublicensee” shall mean any third party to whom LICENSEE has granted a license to make, have made, use and/or sell Licensed Product or Licensed Process under the Technology (a “Sublicense”). |
1.16 | “Technology” shall mean all proprietary information known by the Inventors on or before the Effective Date, reasonably necessary to practice or use the Know-How relating to the Study, including but not limited to, information, data, techniques, biological materials, methods, protocols, and the like, to the extent they exist or have been developed on or before the Effective Date. |
1.17 | “Territory” shall mean the world. |
2. |
2.1 |
a. | The UNIVERSITY hereby grants to LICENSEE and LICENSEE hereby accepts an exclusive license in the Territory for the Field of Use, under the Technology and Know-How to research, develop, make, have made, use, sell and import the Licensed Products and/or Licensed Processes. |
b. | Subject to Section 2.2 and 2.3, the UNIVERSITY hereby grants to LICENSEE an exclusive, worldwide license in the Field of Use to the Technology to research, develop, make, have made, use, sell and import Licensed Products and/or Licensed Processes. |
2.2 |
2.3 |
2.4 |
a. | Subject to the terms and conditions of this Section 2.4 and otherwise as set forth in this Agreement, LICENSEE may grant Sublicenses (through multiple tiers) to third parties from time to time; provided, that, solely for any Sublicense to an Excluded Entity, LICENSEE has requested and obtained the prior written approval of UNIVERSITY. Each Sublicensee shall agree in writing with LICENSEE to accept the conditions and restrictions |
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[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
agreed to by LICENSEE in this Agreement. Sublicenses with any exclusivity must include diligence requirements commensurate with the diligence requirements under this Agreement. Any agreement granting a Sublicense shall state that the Sublicense is subject to the termination of this Agreement. LICENSEE shall have the same responsibility for the activities of any Sublicensee as if the activities were directly those of LICENSEE. |
b. | For clarity, royalties on Net Sales negotiated and agreed upon under this Agreement are “pass-through” by nature. An earned royalty is calculated as a percentage of Net Sales of Licensed Products and/or Licensed Processes of LICENSEE or Sublicensee(s). |
c. | LICENSEE shall provide UNIVERSITY with a copy of each Sublicense agreement and any other agreement which transfers intellectual property rights granted hereunder to a third party (other than routine research and development agreements, such as agreements with contract research organizations), within [*] days following the execution of the Sublicense agreement. |
d. | Notwithstanding the Sublicensee’s payment obligation to LICENSEE, LICENSEE shall be directly responsible for all royalties and payments due pursuant to Section 3. |
3. |
3.1 |
a. | License issue fee of seventy-five thousand U.S. dollars (U.S. $75,000) is due to UNIVERSITY within [*] days of the Effective Date of this Agreement. |
b. | On and after such time as the Licensed Product has received Regulatory Approval for the Approved ALS Indication, running royalty on licensed Technology is calculated as a percentage equal to three-quarters of one percent (0.75%) of the annual Net Sales of the Licensed Product(s) or Licensed Process(es) which use the Technology. |
c. | By the first (1st) day of each anniversary specified below of the Effective Date and until the fourteenth (14th) anniversary of the Effective Date or the earlier termination of this Agreement, LICENSEE agrees to pay UNIVERSITY an annual fee of: |
(i) | [*] on the [*] anniversary; |
(ii) | [*] on the [*] anniversary; |
(iii) | [*] on the [*] anniversary; |
(iv) | [*] on the [*] through [*] anniversaries; and |
(v) | [*] on the [*] anniversary and every anniversary thereafter until the fourteenth (14th) anniversary of the Effective Date or the earlier termination of this Agreement. |
Each such annual fee is fully creditable towards any other consideration, including royalty and milestone payments that are, as set forth herein, due to the UNIVERSITY by LICENSEE during any calendar in which such annual fee is paid.
d. | Royalties are payable on a Licensed Product-by-Licensed Product or Licensed Process-by-Licensed Process and country-by-country basis beginning on the date of first commercial sale of such Licensed Product or Licensed Process in such country and ending on the termination of the Term. |
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[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
3.2 |
3.3 |
3.4 |
3.5 |
4. |
LICENSEE represents and warrants to UNIVERSITY as of the Effective Date as follows:
4.1 | LICENSEE is a corporation duly organized, validly existing and in good standing under the laws of the country of Denmark and has all requisite corporate power and authority to own and operate the business in which it is now engaged or currently proposed to be engaged. LICENSEE is duly qualified to do business as a foreign corporation and is in good standing in such countries, states or jurisdictions as is necessary to enable it to carry on its business or own its properties. |
4.2 | There is no action, suit proceeding or investigation pending or, to LICENSEE’s knowledge, threatened against LICENSEE. |
4.3 | LICENSEE is in compliance with all United States federal, state and local environmental laws and there are no conditions currently existing or contemplated which are likely to subject LICENSEE to damages, penalties, injunctive relief, removal costs, remedial costs or cleanup costs under any such laws or assertions thereof. |
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[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
4.4 | LICENSEE will in good faith consider Institutions’ interests in the Licensed Product prior to terminating this Agreement under section 14.l (Termination) and will meet to discuss the reasons for such termination with Institutions if any Institution so requests. |
5. |
5.1 |
5.2 |
5.3 |
5.4 |
6. |
The term of this Agreement shall commence on the Effective Date and shall remain in effect until the date that is ten (10) years from the first commercial sale of the Licensed Product or Licensed Process in such country (on a country-by-country basis, the “Term”), unless terminated earlier in accordance with the terms and conditions of this Agreement.
7. |
7.1 |
7.2 |
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7.3 |
8. |
8.1 |
a. | LICENSEE will defend, indemnify and hold harmless the Institutions, Institutions Affiliates, and their respective trustees, officers, faculty, employees and students (the “Institutions’ Indemnitees”) against any and all losses, expenses, claims, actions, lawsuits and judgments thereon (including attorney’s fees through the appellate levels) (collectively “ Liabilities”) which may be brought against Institutions’ Indemnities by third parties as a result of or arising out of: (i) any theory of product liability (including, but not limited to, actions in the form of contract, tort, warranty, or strict liability ) concerning any product, process, or service made, used, sold or performed pursuant to any right or license granted under this Agreement; (ii) LICENSEE’s breach of this Agreement; or (iii) the use, production, manufacture, sale, lease, consumption or advertisement by LICENSEE, its Sublicensees or Affiliates or its or their agents or employees of any Licensed Products or Licensed Processes; provided however, LICENSEE shall not defend, indemnify or hold harmless any Institutions’ Indemnitee from any Liabilities to the extent that such Liabilities are finally determined to have resulted from the gross negligence or intentional misconduct of any Institution or Institution Indemnitee. |
b. | LICENSEE will defend, indemnify and hold harmless the Institutions’ Indemnities against any and all judgments and damages arising from any and all third party claims of infringement that may be asserted against any Institution Indemnities because of the manufacture, use, promotion and sale of Licensed Products or Licensed Processes. LICENSEE will bear all costs and expenses incurred in connection with the defense of any such claims or as a result of any settlement made or judgment rendered on the basis of such claims. LICENSEE agrees to provide attorneys which shall be approved by Institutions’ Indemnities at their sole and absolute discretion to defend against any actions brought or filed against any Institution Indemnitee hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought; provided however, that any Institution Indemnitee shall have the right to retain its own counsel, at the reasonable expense of LICENSEE, if representation of such Institution Indemnitee by counsel retained by LICENSEE would be inappropriate because of conflict of interests or otherwise. LICENSEE agrees to keep Institutions informed of the progress in the defense and disposition of such claim, and to consult with Institutions prior to any proposed settlement. |
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[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
8.2 |
a. | Institutions shall have no responsibility with respect to LICENSEE’s own trademarks and trade name, and LICENSEE in respect to the use thereof will defend, indemnify and hold harmless Institutions against any and all third party claims. |
b. | NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE FOR ANY SPECIAL, LOST PROFIT, EXPECTATION, INCIDENTAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY OR OTHER INDIRECT DAMAGES IN CONNECTION WITH ANY CLAIM ARISING OUT OF OR RELATED TO THIS AGREEMENT, WHETHER GROUNDED IN TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, CONTRACT, OR OTHERWISE. UNIVERSITY’s TOTAL LIABILITY FOR ANY AND ALL CLAIMS OR ACTIONS ARISING FROM OR RELATED TO THIS AGREEMENT WILL IN NO EVENT EXCEED THE TOTAL AMOUNT PAID BY LICENSEE TO UNIVERSITY, BY AND ON BEHALF OF ITSELF AND THE INSTITUTIONS. |
8.3 |
8.4 |
9. |
9.1 | By [*] of each year, LICENSEE shall furnish to UNIVERSITY a written annual report covering the preceding calendar year. The report shall include information sufficient to enable UNIVERSITY to satisfy reporting requirements of the Government and for UNIVERSITY to ascertain progress by LICENSEE toward meeting the Agreement’s diligence requirements. Each report shall describe, where relevant: LICENSEE’s progress toward commercialization of Licensed Product(s) and/or Licensed Process(es), including work completed, key scientific discoveries, summary of work-in-progress, current schedule of anticipated events or milestones, market plans for introduction of the Licensed Product(s) or Licensed Process(es), and significant corporate transactions involving the Licensed Product(s) or Licensed Process(es). LICENSEE shall notify each Institution’s Office of Technology Transfer prior to commencing any clinical trials at Institution. In addition, the report shall specify (a) the number or amount of Licensed Product(s) and Licensed Process(es) sold hereunder by LICENSEE and/or its Affiliates or Sublicensees, if any; (b) the total xxxxxxxx for all Licensed Product(s) and Licensed Process(es) sold, if any; (c) deductions as applicable; (d) total royalties due, and (e) the names and addresses of all Sublicensees, if any. |
9.2 | For a period of [*] years from the date of each report pursuant to Section 9.1, LICENSEE shall keep records adequate to verify each such report and accompanying payment made to the UN IVERSITY under this Agreement, and an independent Certified Public Accountant or Accounting Finn selected by UNIVERSITY and acceptable to LICENSEE (the “Independent Accountant”) |
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[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
may have access, on reasonable notice during regular business hours, not to exceed twice per year, to such records to verify such reports and payments. LICENSEE’s acceptance of UNNERSITY’s selection of said Independent Accountant shall not be unreasonably withheld. Such Independent Accountant shall not disclose to UNIVERSITY any information other than that information relating solely to the accuracy of, or necessity for, the reports and payments made hereunder. The fees and expense of the Independent Accountant performing such verification shall be borne by UNIVERSITY, unless the audit reveals an underpayment of royalty by more than [*], in which case the cost of the audit shall be paid by LICENSEE. |
10. |
LICENSEE shall act in good faith to maintain satisfactory standards in respect to the nature of the Licensed Product or Licensed Process manufactured and/or sold by LICENSEE. LICENSEE shall act in good faith to ensure that all Licensed Products or Licensed Processes manufactured and/or sold by it shall be of a quality which is appropriate to products or processes of the type here involved. LICENSEE agrees that similar provisions shall be included by Sublicenses of all tiers.
11. |
11.1 |
a. | by providing UNIVERSITY with written notice of the proposed assignment, including the proposed assignee’s contact information, at least [*] days prior to the date of assignment, and obtaining UNIVERSITY’s express written consent to the proposed assignment, which consent shall not be unreasonably withheld; or |
b. | as part of a sale or change of control, regardless of whether such a sale or change of control occurs by operation of law or through an asset sale, stock sale, merger or other combination, or any other transfer of: (i) LICENSEE’s entire business; or (ii) that part of LICENSEE’s business that exercises all rights granted under this Agreement. |
11.2 |
11.3 |
11.4 |
12. |
12.1 |
a. | is or becomes generally available to and known by the public other than as a result of, directly or indirectly, any breach of this Section 12 by the Receiving Party or any of its employees, agents or representatives; |
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[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
b. | is or becomes available to the Receiving Party on a non-confidential basis from a third party source, provided that such third party is not and was not prohibited from disclosing such Confidential Information; |
c. | was known by or in the possession of the Receiving Party or its employees, agents or representatives prior to being disclosed by or on behalf of the Disclosing Party; or |
d. | was or is independently developed by the Receiving Party without reference to or use of, in whole or in part, any of the Disclosing Party’s Confidential Information. |
12.2 |
a. | protect and safeguard the confidentiality of the Disclosing Party’s Confidential Information with at least the same degree of care as the Receiving Party would protect its own Confidential Information, but in no event with less than a commercially reasonable degree of care; |
b. | not use the Disclosing Party’s Confidential Information, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and |
c. | not disclose any such Confidential Information to any person or entity, except to the Receiving Party’s employees, agents or representatives who need to know the Confidential Information to assist the Receiving Party, or act on its behalf, to exercise its rights or perform its obligations under this Agreement and who are bound by written obligations of confidentiality and restrictions on use that cover such Confidential Information and are at least as stringent as those set forth in this Agreement. |
12.3 |
12.4 |
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[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
12.5 |
12.6 |
13. NOTICE. Any notice, payment, report or other correspondence (hereinafter collectively referred to as “correspondence”) required or permitted to be given hereunder shall be mailed by certified mail or delivered by hand to the Party to whom such correspondence is required or permitted to be given hereunder. If mailed, any such notice shall be deemed to have been given when mailed as evidenced by the postmark at point of mailing. If delivered by hand, any such correspondence shall be deemed to have been given when received by the Party to whom such correspondence is given, as evidenced by written and dated receipt of the receiving Party.
All correspondence to LICENSEE shall be addressed as follows:
Chief Executive Officer
Orphazyme ApS
Ole Maaloes Vej 3
DK-2200 Copenhagen N
Denmark
WITH A COPY TO:
Dechert LLP
Attention: Xxxxx X. Xxxxxxxx
0000 X Xxxxxx XX
Xxxxxxxxxx, XX 00000
All correspondence to UNIVERSITY shall be addressed, in duplicate, as follows:
FOR NOTICE:
Assistant Vice President
Financial Operations
University of Miami
0000 Xxxxx Xxxxx Xxxxxxx, Xxxxx 0000
Gables Xxx Xxxxx
Xxxxx Xxxxxx, XX 00000
WITH A COPY TO:
Office of the General Counsel
University of Miami
0000 Xxxxx Xxxxx Xxxxxxx, Xxxxx 0000
Gables Xxx Xxxxx
Xxxxx Xxxxxx, XX 00000
FOR NOTICE AND PAYMENT:
Office of Technology Transfer
University of Miami
0000 XX 0xx Xxxxxx, Xxxxx 000
Xxxxx, XX 00000
Either Party may change the address to which correspondence to it is to be addressed by notification as provided herein.
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[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
14. |
14.1 |
a. | LICENSEE shall have the right to terminate this Agreement upon [*] prior written notice to UNIVERSITY, during which time LICENSSEE shall pay any amounts due and outstanding to UNIVERSITY. |
b. | UNIVERSITY and LICENSEE shall have the right to terminate this Agreement if the other Party commits a material breach of an obligation under this Agreement and fails to cure any such breach within [*] of receipt of written notice from the non-breaching Party. A material breach shall include but not be limited to the following: (i) failure to deliver to UNIVERSITY any payment at the time such payment is due under this Agreement, which payment is not the subject of a good faith dispute, (ii) failure to meet or achieve milestone schedule, (iii) failure to possess and maintain required insurance coverage in any material respects, or (iv) knowing delivery of a false report to UNIVERSITY. Such termination shall be effective upon further written notice to the breaching Party after failure by the breaching Party to cure. |
c. | If the UNIVERSITY commits a material breach or defaults, then LICENSEE has no duty to continue the payment of royalties and other consideration as set forth in Article 3 and Section 5.4 of this Agreement. |
d. | The license and rights granted in this Agreement have been granted on the basis of the special capability of LICENSEE to perform research and development work leading to the manufacture and marketing of the Licensed Product(s) or Licensed Process(es). Accordingly, LICENSEE covenants and agrees that in the event any proceedings under Xxxxx 00, Xxxxxx Xxxxxx Code or any amendment thereto, be commenced by or against LICENSEE, and, if against LICENSEE, said proceedings shall not be dismissed with prejudice before either an adjudication in bankruptcy or the confirmation of a composition, arrangement, or plan of reorganization, or in the event LICENSEE shall be adjudged insolvent or make an assignment for the benefit of its creditors, or if a writ of attachment or execution be levied upon the license hereby created and not be released or satisfied within [*] thereafter, or if a receiver be appointed in any proceeding or action to which LICENSEE is a party with authority to exercise any of the rights or privileges granted hereunder and such receiver be so discharged within a period of [*] after his appointment, any such event shall be deemed to constitute a breach of this Agreement by LICENSEE and UNIVERSITY, at the election of UNIVERSITY, but not otherwise, ipso facto, and without notice or other action by UNIVERSITY, shall terminate this Agreement and all rights of LICENSEE hereunder and all rights of any and all persons claiming under LICENSEE. |
e. | LICENSEE agrees that breach of terms of this Agreement would immediately and irreparably damage UNIVERSITY in a way not capable of being fully compensated by monetary damages and accordingly, UNIVERSITY is entitled to seek injunctive relief in addition to such other relief to which it may be entitled at law or in equity. |
f. | Upon termination of this Agreement for any reason, LICENSEE shall promptly pay to UNIVERSITY any amounts accrued as of the effective date of such termination. Any termination of this Agreement shall be without prejudice to UNIVERSITY’s right to recover all amounts accruing to UNIVERSITY prior to such the effective date termination and cancellation. Except as otherwise provided, should this Agreement be terminated for any reason, LICENSEE shall have no rights, express or implied, under any intellectual property rights which are the subject matter of this Agreement including Technology, nor have the right to recover any royalties paid to UNIVERSITY hereunder. Upon termination, LICENSEE shall have the right to dispose of Licensed Products then in their possession |
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[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
and to complete existing contracts for such Licensed Products, so long as contracts are completed within [*] from the date of termination, subject to the payment of royalties to UNIVERSITY as provided in Section 3 hereof; it being understood and agreed, following the termination of this Agreement for any reason and completion of existing contracts for such Licensed Products as described in this sentence, LICENSEE shall have no further payment obligations (other than those accrued prior to the termination) to UNIVERSITY under this Agreement. LICENSEE agrees to destroy progeny and derivatives thereof remaining in LICENSEE’s possession after [*] from the date of termination. Failure to terminate on any basis shall not prejudice or impact the UNIVERSITY’s rights and ability to subsequently terminate for the same or a related basis. |
g. | Notwithstanding anything to the contrary, UNIVERSITY, by and on behalf of itself and each of the Institutions, hereby grants to LICENSEE and LICENSEE hereby accepts a non-exclusive, royalty-free, fully paid-up, non-terminable, sublicensable (through multiple tiers) license in the Territory for the Field of Use, to use the safety data generated under the Study to research, develop, make, have made, use, sell and import any pharmaceutical product (including the Licensed Product). |
14.2 |
a. | Prior to the commencement of clinical trials, LICENSEE must maintain commercial general liability insurance in the amounts of not less than [*] per incident and [*] annual aggregate. After the commencement of the first clinical trial for the first Licensed Product or Licensed Process but prior to the first commercial sale of a Licensed Product or Licensed Process, LICENSEE must maintain commercial general liability insurance of not less than [*] per incident and clinical trials liability insurance of not less than [*]. After the first commercial sale of a Licensed Product or Licensed Process, LICENSEE must maintain commercial general liability insurance in the amounts of not less than [*] per incident and [*] annual aggregate. Immediately prior to the commencement of the first clinical trial for the first Licensed Product or Licensed Process, [*]. After the first commercial sale of a Licensed Product or Licensed Process, LICENSEE shall maintain products liability/completed operations and clinical trials insurance coverage in the amount of [*]. |
b. | LICENSEE shall not cancel such insurance without [*] prior notice to UNIVERSITY. Such cancellation shall be cause for termination. |
c. | The terms of this Section 14.2 shall survive termination of this Agreement. |
14.3 |
14.4 |
a. | This Agreement shall be considered as having been entered into in [*], and shall be construed and interpreted in accordance with the laws of [*]. In any action or proceeding arising out of or relating to this Agreement (an “Action”), each of the Parties hereby irrevocably submits to the jurisdiction of [*], and further agrees that any Action shall be heard and determined in such [*] court. Each Party hereby irrevocably waives, to the fullest extent it may effectively do so, the defense of an inconvenient forum to the maintenance of any Action in [*]. |
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b. | If a dispute arises between the Parties relating to the interpretation or performance of this Agreement or the grounds for the termination thereof, the Parties agree to hold a meeting, attended by individuals with decision-making authority regarding the dispute, to attempt in good faith to negotiate a resolution of the dispute prior to pursuing other available remedies. If the dispute remains unresolved [*] after the first meeting for the purpose of dispute resolution, then each Party shall have the right to pursue other remedies legally available to resolve the dispute. |
14.5 |
14.6 |
14.7 |
14.8 |
a. | The provisions of Sections 1 (Definitions), 8 (Indemnification and Limitation of Liability), 11 (Assignment), 12 (Confidentiality), 13 (Notice) and 14 (Miscellaneous Provisions), shall survive the termination or expiration of this Agreement and shall remain in full force and effect. |
b. | The provisions of this Agreement which do not survive termination or expiration hereof (as the case may be) shall, nonetheless, be controlling on, and shall be used in construing and interpreting, the rights and obligations of the Parties hereto with regard to any dispute, controversy or claim which may arise under, out of, in connection with, or relating to this Agreement. |
c. | Sublicenses in good standing shall survive termination of this license as a direct license from UNIVERSITY, provided that Sublicensees assume the obligations set forth in the definitive agreement. UNIVERSITY will enter into a direct agreement with such Sublicensees upon LICENSEE’s written request. |
14.9 |
14.10 | NON-WAIVER. No failure or delay on the part of a Party in exercising any right hereunder will operate as a waiver of, or impair, any such right. No waiver of any of the provisions of this Agreement shall be effective unless it is in writing, and signed by the Party against whom it is asserted, and any such written waiver shall only be applicable to the specific instance to which it relates and shall not be deemed to be a continuing or future waiver. No single or partial exercise of any such right will preclude any other or further exercise thereof or the exercise of any other right. No waiver of any such right will be deemed a waiver of any other right hereunder. |
14.11 |
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14.12 |
14.13 |
14.14 |
14.15 |
14.16 |
14.17 | TAX-EXEMPT STATUS. LICENSEE acknowledges that Institutions’ hold the status of an exempt organization under the Internal Revenue Code of 1986, as amended. LICENSEE also acknowledges that certain facilities in which the Technology was developed may have been financed through offerings of tax-exempt bonds. If the Internal Revenue Service determines, or if Institutions’ reasonably determine, that any term of this Agreement jeopardizes the tax-exempt status of Institutions or the bonds used to finance Institutions’ facilities, the relevant term is invalid and the Parties shall modify the term accordingly. |
{Signature Page Follows.}
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LICENSEE | UNIVERSITY on behalf of itself, EMORY and MGH | |||
/s/ Xxxxxx Xxxx Vadsholt |
/s/ Xxxxx Xxx Xxxxxx, Ph.D. | |||
Signature | Signature | |||
Xxxxxx Xxxx Vadsholt |
Xxxxx Xxx Xxxxxx, Ph.D. | |||
Printed Name | Printed Name | |||
Chief Financial Officer |
Vice Xxxxxxx for Innovation | |||
Printed Title | Printed Title |
{Signature Page to University of Miami and Orphazyme License Agreement}
[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
APPENDIX A
TECHNOLOGIES/INTELLECTUAL PROPERTY
[*]
[*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.