DATED 12th October 2017
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Exhibit 4.4
(1) OXFORD UNIVERSITY INNOVATION LIMITED
ABCA4 Stargardts disease program
[*] = CONFIDENTIAL TREATMENT REQUESTED
THIS AGREEMENT is made on the 12th day of October 2017 ("Effective Date")
(2) |
Nightstarx Limited (Company Registration No. 08551822), whose registered office is Xxxxx Building, 000 Xxxxxx Xxxx, Xxxxxx, XX0 0XX XX together with its Affiliates (the “Licensee”). |
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• |
Licensee is a private biopharmaceutical company focused on the development of therapies for inherited retinal dystrophies. |
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• |
Licensee and Licensor are already subject to an agreement for the licence of certain gene therapy technology relating to choroideremia (OUI project no. 7126) dated 13 November 2013, as amended (“Original Licence”) and five further programmes relating to RPGR therapy, Best’s disease, [*], [*], [*] (OUI project no’s [*], [*], [*], [*] and [*] respectively) dated 3rd November 2015 (“Further Licences”). |
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• |
Licensee wishes to acquire a licence to the Licensed Technology, on the terms of this agreement. |
In this agreement (including its Schedules), any reference to a "clause" or "Schedule" is a reference to a clause of this agreement or a schedule to this agreement, as the case may be. Words and expressions used in this agreement have the meaning set out in Schedule 1 and Schedule 2.
2.2 |
Subject to clause 4, the Licence is (i) exclusive in relation to the Application and the Exclusive Licensed Know-how; and (ii) non-exclusive in respect of all Licensed Know-how that is not Exclusive Licensed Know-how. Subject to Clauses 4 and 7, OUI retains unrestricted rights to use and license others to use and license the Licensed Technology outside the Field. |
[*] = CONFIDENTIAL TREATMENT REQUESTED
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such documents are in the possession of OUI or the University and readily available to be supplied. |
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b. |
use reasonable endeavours to facilitate the supply of the samples by the University under the terms of the Material Transfer Agreement. |
2.4 |
Subject to clause 2.5 below except in relation to sub-licenses to Affiliates, the Licensee may grant sub-licences (through multiple tiers) under the Licence, provided that: |
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(a) |
the sub-licensee has obligations to the Licensee commensurate with those which the Licensee has to OUI under this agreement, except where it is not legally possible to include such obligations in the sub-licence; and |
2.5 |
Licensee shall be entitled to sub-license any of the rights under the Licence through multiple tiers and without restriction save that (i) no sub-licence may be granted to a [*] without Licensor’s prior written consent; and (ii) OUI shall have a right to object to the grant of a sub-licence under the Licence by Licensee to other third parties solely in the following specific circumstances: |
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2.5.1 |
OUI may only object in respect of a proposed sub-licensee if, due to the nature of that proposed sub-licensee’s business, the grant of the sub-licence to that entity will, in the reasonable and measured opinion of OUI, have a material detrimental impact on the reputation of the University by its association; and |
2.6 |
If OUI has objected to the grant of a sub-licence in accordance with Clause 2.5.2, Licensee may either accept that objection and not grant (or terminate) the sub-licence or if it disputes the objection the following shall apply: |
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2.6.1 |
OUI shall procure that representatives from OUI and the University shall meet with Licensee within ten (10) days of the objection to enable OUI, Licensee and the University to discuss the proposed sub-licence and the reasons for the perceived risk that an association will have a material detrimental impact on the University’s reputation and, in good faith, seek ways in which to overcome or mitigate such risk to a pragmatic and reasonably acceptable position; |
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2.6.2 |
if OUI agrees that the risk is acceptable or OUI and Licensee agree on any conditions to include in a sub-licence to avert or mitigate the risk then Licensee shall be entitled to grant (or maintain) the sub-licence subject to any agreement reached between OUI and Licensee; |
[*] = CONFIDENTIAL TREATMENT REQUESTED
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determination identified below (the “Appointed Expert”). The nomination shall be subject to the Appointed Expert agreeing to be so appointed and the terms of that appointment set by the Wellcome Trust. The costs of the Appointed Expert shall be borne by [*]. The Appointed Expert shall be entitled to consider any information presented to the Appointed Expert by OUI or Licensee (provided that each party shall copy to the other party all information provided to the Appointed Expert at the same time) and any other information that the Appointed Expert may consider relevant. The Appointed Expert shall make his or her decision as expert and not as arbiter, and the decision of the Appointed Expert shall be final and binding save in the case of manifest error. If, in the Appointed Expert’s opinion the Appointed Expert considers the grant of a sub-licence to the third party objected to by OUI will, by virtue of the nature of the business of that third-party entity, be materially detrimental to the reputation of the University, then Licensee shall not grant (or shall terminate) such sub-licence. In all other circumstances, irrespective of any objection by OUI or the University, Licensee shall be entitled to grant (or maintain) the sub-licence without restriction or condition. OUI and Licensee hereby irrevocably agree, accept and acknowledge that neither the Wellcome Trust, the Chairman of the Wellcome Trust nor the Appointed Expert shall have any liability to OUI or Licensee (or any third party or any other person) by virtue of the provisions of this Clause or exercise of decisions pursuant this Clause, and OUI and Licensee hereby undertake not to make or bring any claim against any of the Wellcome Trust, the Chairman of the Wellcome Trust or the Appointed Expert with respect to performance in connection with the foregoing or this Agreement. |
3.1 |
The Licence in clause 2 shall include an exclusive licence within the Field to all of Inventor Improvements. |
3.2 |
The Licensee acknowledges and agrees that all Intellectual Property Rights in Inventor Improvements belong to OUI. |
3.4 |
Licensor shall, from time to time as appropriate keep Licensee reasonably informed of any and all Inventor Improvements. |
4.3 |
OUI will ask the University to give to the Licensee an outline of any material related to the Licensed Technology intended for publication. The Licensee may request that |
[*] = CONFIDENTIAL TREATMENT REQUESTED
publication be delayed for a period no longer than [*] (or no longer than [*] if agreed by Licensor) from the date of notification if such delay is necessary in order to protect the Licensed Technology. If no request for delay is received within 30 days of the date of notification, the University will be free to assume that the Licensee has no objection to the proposed publication. |
5 |
Filing and Maintenance |
5.1 |
The Licensee’s contribution to the patent costs of the Application incurred by OUI prior to the parties entering into this agreement is included as part of the Signing Fee. |
5.3 |
Where the Application is prosecuted in the USPTO and the Licensee is a small business concern as defined under the US Small Business Act (15USC632) OUI intends to pay reduced USPTO patent fees under US patent law 35USC 41(h)(1). The Licensee will notify OUI as soon as reasonably possible if it or a sub-licensee ceases to be a small business concern as defined under the US Small Business Act (15USC632) or becomes aware of any other reason why it would not qualify for reduced USPTO patent fees under US patent law 35USC 41(h)(1). |
5.4 |
The Licensee shall inform OUI not less than [*] in advance of the National Phase filing deadline (noted in Schedule 2) of the territories within the scope of the PCT that it wishes to be covered in the National Phase of the Application but which shall as a minimum include those of the Key Territories (which, in respect of the European territory may be covered by a European patent) where the claimed invention of the original Application is reasonably considered by the Licensee (based on patent attorney advice) to be granted and patentable subject matter pursuant to local patent laws. In the event that the Licensee does not give the advance notice, OUI shall then be entitled to proceed with filing the applications [*] in up to [*] territories (with a European Patent classified as one territory) as it may in its sole discretion decide. Where notice is given by the Licensee, OUI shall instruct the prosecuting patent attorneys to enter the Application into the National Phase for each identified territory, and Licensee shall only be responsible for the prosecution, maintenance and renewal fees for those notified territories. |
[*] = CONFIDENTIAL TREATMENT REQUESTED
Application in those countries notified by Licensee, such costs shall be at [*] cost and expense. |
6.1 |
Each party will notify the other in writing of any unauthorised use, misappropriation or infringement of any rights in the Licensed Technology of which the party becomes aware. |
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(b) |
account to Licensee in respect of any award of profits or damages (including, without limitation, punitive damages) after deduction of all costs (including lawyers’ and patent agents’ fees and expenses that are not recovered from an award of legal costs), claims, demands and liabilities directly arising out of or consequent upon such enforcement activities which were reasonably and properly incurred, which Licensee shall treat as Net Sales for the purposes of clause 8; and |
[*] = CONFIDENTIAL TREATMENT REQUESTED
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including, without limitation, any claims affecting the scope, enforceability or validity of the Licensed Technology. |
7.3 |
Licensor shall keep confidential, and use reasonable endeavours to procure the University, any academic institution and individuals licensed pursuant to clause 4.1, shall keep confidential and not use the Licensed Technology other than as expressly permitted under clause 4. The exceptions to confidentiality under clause 7.4 below shall not apply to the restrictions under this clause 7.3 in respect of the Licensed Technology. The restrictions under this clause 7.3 in respect of the Licensed Technology shall not apply to information that is or becomes public (other than by publication after the date of this agreement by Licensor or any Academic Licensee(s)) or which Licensee approves (in writing) may be made public. The foregoing shall not affect or release OUI from its obligations under Clause 4.2.1 or 7.1. |
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(a) |
is known to the receiving party before disclosure, and not subject to any obligation of confidentiality owed to the disclosing party; or |
7.5 |
The receiving party shall not be in breach of its obligations under clause 7.1 to the extent it makes a disclosure of the disclosing party's Confidential Information where |
[*] = CONFIDENTIAL TREATMENT REQUESTED
and to the extent such disclosure is required to be made by mandatory law. In such circumstances, the receiving party shall, so far as is practicable and permitted by law, |
7.6 |
notify the disclosing party prior to making such disclosure and co-operate with the disclosing party to assist it in seeking confidential treatment of such Confidential Information required to be disclosed. |
Signing Fee
8.1 |
Licensor will invoice the Licensee for the Signing Fee shortly after the Effective Date and the Licensee must settle the invoice within thirty (30) Business Days of receipt of the same. |
Royalties
8.2 |
In respect of any Quarterly reporting period for which Net Sales and royalties are required to be reported by the Licensee pursuant to clause 10.2, the Licensee will (subject to Clauses 8.13 and 8.14) pay to OUI a royalty equal to the Royalty Rate on all those Net Sales made during that Quarterly reporting period, on a country by country basis, where during each of those Quarterly reporting periods any one or more of the following circumstances have prevailed with respect to such country during that Quarter: |
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8.2.2 |
the Licensee has Market Exclusivity throughout the world; |
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8.2.3 |
the Licensee has Market Exclusivity throughout the Region within which the particular country exists; or |
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8.2.4 |
the Licensee has Market Exclusivity in the country; |
and where those circumstances do not prevail (“Lost Exclusivity”) sales of such Licensed Product in such country for that particular Quarter under the Licence shall be deemed to have been pursuant to a fully paid up, royalty free, licence and right, and no payments under this Clause 8.2 for or in respect of such Licensed Product in such country shall be due in that Quarter.
Milestones
8.5 |
Subject to clause 8.14, the Licensee will notify OUI as soon as possible after it or any sub-licensee achieves any Milestone, and pay to OUI the Milestone Fee in respect of |
[*] = CONFIDENTIAL TREATMENT REQUESTED
each Milestone within thirty (30) Business Days of the date on which each Milestone is achieved by the Licensee or a sub-licensee. |
Payment Principles
Miscellaneous Payment Provisions
8.8 |
The Licensee will make all payments in pounds sterling or any currency replacing pounds sterling in its entirety. |
8.12 |
If the Licensed Product is of a description covered by the Medicines Access Policy, the Licensee shall adhere to the requirements of the Medicines Access Policy. |
Royalty Stack
Avoiding Double Royalties
[*] = CONFIDENTIAL TREATMENT REQUESTED
royalty is payable for such product, process or technique. Furthermore, to the extent any Licensed Product under this licence is Marketed or administered using any of the surgical techniques and/or protocols within the definition of Licensed Technology under the Original Agreement, provided that OUI does not control any patent (pending or granted) claiming such surgical techniques and/or protocols (which would be infringed by use of the same in Marketing or administering the Licensed Product) in the country of sale of the Licensed Product, no royalty shall be triggered or payable under the Original Agreement or any of the other OUI Licences for such use. |
9. |
Development Obligations |
9.1 |
The Licensee shall use reasonable endeavours to develop, exploit and Market the Licensed Product in accordance with the Development Plan. |
9.2 |
If the Licensee proposes to make a material amendment to the Development Plan, it shall as soon as practicable inform OUI giving sufficient details and provide OUI with such additional information relevant to those material amendments as OUI may reasonably request. OUI shall approve the Licensee’s material amendments to the Development Plan provided that those amendments are reasonable and reflect the efforts reasonably required of a prudent drug development company (of equivalent resource as the Licensee) having regard to, without limitation, regulatory and scientific guidance from regulatory authorities and industry leaders. For the avoidance of doubt, upon the Licensee receiving OUI’s approval the revised development plan shall become the Development Plan and any non-material amendments shall be deemed to have amended the Development Plan without requiring OUI’s consent. |
9.3 |
Without prejudice to Licensee’s obligations under clause 9.1 and 9.2 above, the Licensor shall, subject to clause 9.4, have the right to terminate the Licence on a country by country basis if: |
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9.3.1 |
with respect to a country within the Major Market, by the [*] the Licensed Product has not been Exploited in that country; or, |
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9.3.2 |
in respect of a country within the Secondary Market, by the [*], the Licensed Product has not been Exploited in that country in the Secondary Market. |
9.4 |
The right of OUI to terminate the Licence in respect of a country under clause 9.3 is subject to: |
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9.4.1 |
Licensor serving a written notice on Licensee identifying the country or countries in respect of which it is seeking to exercise its rights under clause 9.3; and, |
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9.4.2 |
Licensee has not begun Exploitation in such country or countries within [*] of the notice served under clause 9.4.1. |
10.2 |
The Licensee will provide OUI with a royalty report within [*] after the close of each Quarter of the Licence Year for each Licensed Product Marketed by the Licensee and its sub-licensees in that Quarter. Each Royalty Report will: |
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(b) |
provide a calculation of the royalties due including details of all relevant currency conversions made; |
[*] = CONFIDENTIAL TREATMENT REQUESTED
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(c) |
provide a statement showing whether or not aggregate Net Sales due exceed [*], and if so by how much until payments due in respect of Licensed Products under clause 8.8 cease to be payable; |
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(e) |
set out details of any deductions made to calculate the Net Sales; |
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(g) |
provide a statement showing whether or not royalties due exceed the Annual Maintenance Fee and, if so, by how much; and |
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(h) |
set out details of any deductions made under clause 8.13 and 8.14. |
The Licensee must pay OUI the royalties due in respect of the Quarter just closed at the same time as the Licensee delivers the Royalty Report.
10.5 |
The Licensee must keep complete and accurate accounts of all Licensed Products manufactured, used or Marketed by the Licensee in each Licence Year for at least [*]. OUI may, through an independent certified accountant appointed by OUI (“the Auditor”), audit all such accounts on at least [*] written notice no more than [*] for the purpose of determining the accuracy of the Royalty Reports and payments. The Auditor shall be: |
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10.5.1 |
permitted by the Licensee to enter the Licensee's principal place of business upon reasonable notice to inspect such records and accounts; |
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10.5.2 |
entitled to take copies of or extracts from such records and accounts; |
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10.5.3 |
given all other information by the Licensee as may be necessary or appropriate to enable the amount of royalties payable to be ascertained including the provision of relevant records; and |
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10.5.4 |
shall be allowed access to and permitted to conduct interviews of any sales, engineering or other staff of the Licensee in order to verify the accuracy of the records and accounts and the accuracy of any statements provided to OUI under clause 10.2. |
If on any such audit a shortfall in payments of greater than [*] is discovered by the Auditor in respect of the audit period, the Licensee shall pay OUI's audit costs.
[*] = CONFIDENTIAL TREATMENT REQUESTED
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11.1.1 |
the Application continues to be in force or subsisting in any country; |
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11.1.2 |
the Licensee has Market Exclusivity throughout the world; |
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11.1.3 |
the Licensee has Market Exclusivity throughout any Region; or |
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11.1.4 |
the Licensee has Market Exclusivity in any country. |
Notwithstanding the foregoing, this agreement will expire in its entirety on the twentieth (20) anniversary of the Effective Date.
Upon expiry of this agreement in accordance with the foregoing, Licensee's Licence shall automatically convert to a fully paid up, royalty free, licence in perpetuity without restriction or control over its sub-licensing or assignment.
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(b) |
on thirty (30) days' written notice if the Licensee opposes or challenges the validity of the Application before a patent office or court. |
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(a) |
other than on expiry of this Agreement, must bring all sub-licences it has granted to an end on the same date; and |
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(b) |
shall pay to OUI all outstanding royalties and other sums properly due under this agreement up to the date of termination or expiry; and |
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(c) |
shall provide OUI with details of the stocks of Licensed Products held at the point of termination; |
[*] = CONFIDENTIAL TREATMENT REQUESTED
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(d) |
shall (save as permitted under clause 11.1 or elsewhere in this agreement) cease to have any licence to the Licensed Technology; and |
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(e) |
other than on expiry of this agreement, must [*], destroy all Licensed Products in its possession unless otherwise agreed by OUI (acting reasonably). |
11.8 |
Clauses 7 and 10.5 will survive the termination or expiration of this agreement, for whatever reason, for a period of six (6) years. |
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12.1.1 |
the quality of the Licensed Technology; |
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12.1.2 |
the suitability of the Licensed Technology for any particular use; |
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12.1.3 |
whether use of the Licensed Technology will infringe third-party rights; or |
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12.1.4 |
whether the Application will be granted or the validity of any patent that issues in response to that Application. |
[*] = CONFIDENTIAL TREATMENT REQUESTED
12.7 |
Nothing in this agreement shall limit or exclude any liability for fraud or fraudulent misrepresentation. |
For Licensor to:
Chief Executive Officer, Oxford University Innovation Ltd, Xxxxxx Court, 0 Xxxx Xxx, Xxxxxx, Xxxxxx XX0 0XX
For Licensee to:
Xxxxxxx Xxxxxxxx, NightstaRx Limited, Xxxxx Building, 000 Xxxxxx Xxxx, Xxxxxx, XX0 0XX, Fax: x00 (0)00 0000 0000
[*] = CONFIDENTIAL TREATMENT REQUESTED
rights in any of the Licensed Technology to any person it shall do so expressly subject to the Licensee's rights under this agreement and any additional agreements between the parties relating to the Licensed Technology. |
[*] = CONFIDENTIAL TREATMENT REQUESTED
Academic and Research Purposes means research, teaching or other scholarly use, in each case which is undertaken for the purposes of education and research.
Affiliate means any company or legal entity in any country Controlling or Controlled by the Licensee.
Annual Maintenance Fee means the minimum sum or sums set out in 8.3.
(c) |
any patents and applications which may be granted based on and/or deriving priority (in whole or part) from that application; and |
Business Day means a day, other than a Saturday or Sunday, on which clearing banks are permitted to open in London, England.
Commercialisation means in respect of a country (i) making the Licensed Product available for use or sale in such country, or (ii) a material proportion of patients ordinarily resident in that country and requiring treatment with the Licensed Product receive treatment using the Licensed Product outside of that country, for example through medical tourism, irrespective of whether the Licensed Product is made available for sale or use in that country.
Confidential Information means in relation to each party any materials, ideas, inventions, concepts, data, trade secrets, customer lists, market intelligence, regulatory strategies, clinical data, non-clinical data, research or other information disclosed by or on behalf of that party to the other, including, without limitation:
(a) |
the Licensed Technology, to the extent that it is not disclosed by the Application when published; |
(b) |
the Development Plan; |
(c) |
financial reports including royalty reports; |
(d) |
results from the development of the Licensed Technology; and |
(a) |
ownership of more than fifty percent (50%) of the voting share capital of the relevant entity; or |
(b) |
the ability to direct the casting of more than fifty percent (50%) of the votes exercisable at a general meeting of the relevant entity on all, or substantially all, matters. |
Clinical Patient Care means diagnosing, treating and/or managing the health of persons under the care of an individual having the right to use the Licensed Technology in the event that such Licensed Technology is capable of application in a healthcare setting without further development.
Development Plan means the plan set out in Schedule 3, and updated from time to time in accordance with clause 9.2.
Documents means the documents and clinical data sets identified in Schedule 2.
[*] = CONFIDENTIAL TREATMENT REQUESTED
Exclusive Licensed Know-how means the documents, materials, and specified know-how (information associated with the documents, protocols, and materials) set out in Schedule 2.
Exploited means development and exploitation activities with respect to Licensed Product including, without limitation, initiating or conducting any clinical trials or further clinical trials, obtaining or applying for Regulatory Approvals in any country, negotiating with the relevant reimbursement body, any act of Commercialisation, licensing, promotion, marketing, distribution and sales of the Licensed Product and “Exploited”, “Exploiting” and “Exploitation” shall be construed accordingly. For clarity (i) if a further clinical trial is being undertaken or is pending anywhere in the world with a view to providing data that will enable applications for Regulatory Approvals to be made in any country within the Major Markets or Secondary Markets or (ii) applications for Regulatory Approvals have been made within the Major Markets, in either case in the timeline set forth in the Development Plan, Licensee shall be considered to be Exploiting and fulfilling its development and exploitation obligations.
Fee Income Royalty Rate means the fee income royalty rate set out in Schedule 2.
Field means gene therapy for the treatment of ABCA4 gene therapy for Stargardts disease.
Financial Year means the 12-month period commencing on the first date of the Licensee's corporate financial accounting period.
Improvement means any development of the Licensed Technology which would, if commercially practised, infringe and/or be covered by a claim subsisting or being prosecuted in the Application.
Indemnified Claim means any claim under which OUI and the University are entitled to be indemnified under clause 12.3.
Intellectual Property Rights means all rights in patents (including without limitation any addition, continuation, continuation-in-part, division, reissue, renewal, extension or supplementary protection certificate), inventions, know-how, trade secrets, copyrights, database rights, rights in designs, and all or any other intellectual or industrial property rights, whether or not registered or capable of registration and including all applications and rights to apply for the same in each case for their full and any extended term throughout the world.
Inventor means Xxxxxxxxx Xxxxxx XxxXxxxx and Xxxxxxxx XxXxxxxxxx.
Inventor Improvements means any Improvements made prior to the third anniversary of the date of this agreement solely by the Inventor within the Field, and the Intellectual Property Rights pertaining to them, of which OUI has been made aware and is legally able to license.
Key Territories means the USA, UK, Germany, France, Spain and Italy.
Licence means the licence granted by OUI to the Licensee under clause 2.1.
Licensed Know-how means (i) the Exclusive Licensed Know-how; and (ii) all other confidential information, including know-how and trade secrets, relating to the Application and the Project that has been communicated to the Licensee by OUI in writing before the Effective Date or is communicated to the Licensee by OUI in writing under this agreement within [*] after the Effective Date in each case which is in the records or knowledge of OUI or the University.
Licensed Product means any product, product manufactured process or composition or service which is entirely or partially produced by means of or with the use of, or within the scope of, the Licensed Technology, or any of it.
Licensed Technology means the Application, the Licensed Know-How and Inventor Improvements.
Licensee’s Improvements means any Improvements made from time to time prior to the [*] of the Effective Date by the Licensee, its employees, consultants or agents, or any of
[*] = CONFIDENTIAL TREATMENT REQUESTED
them and the Intellectual Property Rights pertaining to them which the licensee is legally able to license.
Licence Year means each twelve (12) month period (or part thereof) beginning on the Effective Date and thereafter renewing on 1st January of each subsequent year during this agreement.
Major Markets means the United States of America and the European Union (as it exists as of the Effective Date).
Market means, in relation to a Licensed Product, offering to sell, lease, licence or otherwise commercially exploit the Licensed Product or the sale, lease, licence or other commercial exploitation of the Licensed Product.
Material Transfer Agreement means the material transfer agreement R49565 to be entered into between the Licensee and the University relating to the transfer of the samples of the Project materials which are owned by the University
Market Exclusivity in respect of the applicable time period after the first commercial sale of the Licensed Product means the achievement or retention of a certain proportion of the Relevant Market during that time period as determined by reference to the Measurement Procedure which proportion is:
(i) |
not less than [*] of reported procedures in the Relevant Market (“ME1 Figure”); or |
(ii) |
provided always that if for any time period the Measurement Procedure is for any reason unavailable, then for the relevant time period the ME1 Figure shall be set to [*] for that time period. |
For example, if the Measurement Procedure identifies [*] procedures using Licensed Product in the United Kingdom for a given Quarter and the Licensee has sold [*] procedures using Licensed Product in the United Kingdom in the same Quarter then the Licensee has provided [*] of the procedures in the United Kingdom that Quarter.
Measurement Procedure means for any time period a detailed review and analysis of data published by IMS Health Inc. or any successor of IMS Health Inc. [*] for the Relevant Market for that time period. If necessary or reliable data is not available from IMS Health Inc. or its successors then another reputable data aggregator service may be relied upon.
Medicines Access Policy means the policy of the University existing as of the Effective Date to promote access to pharmaceutical and other products and services, the version of which is available at xxx.xxxxx.xx.xx.xx/xxxxxxxxxxxxxxx/xxxxxxxxx/xxxxxx.
Milestone and Milestone Fee means the milestones, and the amounts payable on achievement of each of the milestones, set out in Schedule 2.
Net Sales means the gross selling price received of the Licensed Product in the form in which it is Marketed by the Licensee or any sub-licensee, less:
(c) |
rebates, refunds, allowances, chargebacks, administrative fees given or paid in the normal course of trade; and, |
(d) |
retroactive price reductions, credits or allowances given or paid in the normal course of trade; |
(e) |
customs duties, sales taxes, excise taxes, import/export duties, value-added taxes or other taxes imposed upon and payable with respect to such sales (excluding taxes on income). |
Non-Commercial Use means use of the Licensed Technology for Academic and Research Purposes and includes; the right for the University to license the Licensed Technology to any of its collaborators in connection with and solely for the purposes of University’s Academic
[*] = CONFIDENTIAL TREATMENT REQUESTED
and Research Purposes; but it does not include the right to grant any licence to commercially exploit the Licensed Technology. Neither the receipt of reimbursements for the costs of preparation and shipping of samples of materials provided to third parties as a professional courtesy, in response to publication requests or otherwise, in accordance with academic custom nor the receipt of funding for research shall constitute sale of products or performance of service for a fee. This includes the right for the University to use the Licensed Technology as enabling technology in other research projects (including Clinical Patient Care which is not for the commercial benefit of third parties).
Project means the project referred to in Schedule 4.
Quarter or Quarterly means any period of three calendar months (or part thereof) during a Licence Year ending on 31 March, 30 June, 30 September or 31 December.
Region or Regional means one of the six continents of the world (as defined by the United Nations from time to time) within which the country is classified.
Relevant Market means therapy by means of supply of product or service for treatment of Stargardts Disease using the Same Method of Action.
Regulatory Approval means all marketing authorisations and approvals to be issued by applicable regulatory authorities in relevant territories as are required for the commercial manufacture, sale and marketing of medicinal products (and as applicable any devices) together with all pricing and reimbursement approvals as may be required by any authorities or purchasers.
Royalty Rate means the royalty rate or rates set out in Schedule 2.
Royalty Report means the report to be prepared by the Licensee under clause 10.2.
Secondary Markets means the following countries namely Japan, Brazil, India, China, Russia and the following regions namely Africa and Oceania.
Same Method of Action means methods that deliver the same or similar biological mechanism to that of the biological and medicinal products comprised within the Licensed Product, including without limitation gene therapy, biological medicinal products and other medicinal products.
Signing Fee means the signing fee set out in Schedule 2.
[*] means any entity which develops, sells or manufactures [*].
University means the Chancellor, Masters and Scholars of the University of Oxford whose administrative offices are at the University Offices, Xxxxxxxxxx Xxxxxx, Xxxxxx XX0 0XX.
University Personnel means the University's employees, professors, academics (including visiting academics) and students.
[*] = CONFIDENTIAL TREATMENT REQUESTED
Application: Adeno-Associated Viral Vector System
PCT National Phase filing deadline:June 14, 2017
PCT number: PCT/GB2017/051741
Inventors Named In The Application: [*], [*]
Documents:
Tier 1: documents to be provided at time of execution
Tier 2: documents to be provided within four months of execution
|
Exclusive/Non-Exclusive |
Category |
• Relevant manuscripts/abstracts |
Exclusive (until published) |
Tier 1 |
• Application |
Exclusive |
Tier 1 |
• Details of any data presented at conferences, workshops, symposia (oral, poster or other presentation) |
Non-Exclusive |
Tier 1 |
• Data summaries directly relating to Xxxxxxxxx xxxx therapy |
Exclusive |
Tier 1 |
• Additional unpublished data o Functional (bis-retinoid accumulation) o Toxicity study |
Exclusive |
Tier 1 |
• Protocols |
Non-Exclusive (unless specific to Xxxxxxxxx xxxx therapy) |
Tier 1 |
• Complete ABCA4 gene sequence (by DNA sequencing) |
Exclusive |
Tier 1 |
• Upstream ABCA4 gene sequence (by DNA sequencing) |
Exclusive |
Tier 1 |
• Downstream ABCA4 gene sequence (by DNA sequencing) |
Exclusive |
Tier 1 |
• Descriptions, DNA sequence and plasmid maps or diagrams for plasmids used in the production of AAV vectors ([*]) and details of E. coli host strains used for plasmid production |
Non-Exclusive |
Tier 1 |
• Development history of all plasmids describing design, construction and analysis of structure and function |
Exclusive |
Tier 1 |
• Raw data, lab books and technical/research reports o Review of results showing lack of truncated products from upstream and downstream vectors |
Exclusive |
Tier 2 |
• Source history of all plasmids confirming origin of all components, including copies of Material Transfer Agreements and Permissions to use and sub-licence all components |
Exclusive |
Tier 2 |
• Development history of all AAV viruses describing design, construction and analysis of structure and function |
Non-Exclusive |
Tier 2 |
• Source history of all AAV viruses |
Non-Exclusive |
Tier 2 |
• GMMO risk assessment form and MSDS forms for vectors and plasmids |
Non-Exclusive |
Tier 2 |
• Standard operating procedures and batch manufacturing records or documentation for plasmid and AAV production and analysis |
Non-Exclusive (unless specific to Xxxxxxxxx xxxx therapy) |
Tier 2 |
• Analytical method development, protocols, qualification and testing data |
Non-Exclusive (unless specific to Xxxxxxxxx xxxx therapy) |
Tier 2 |
• Details of reagents used for analytical testing, preparation details of reagents that are not available commercially |
Non-Exclusive (unless specific to Xxxxxxxxx xxxx therapy) |
Tier 2 |
[*] = CONFIDENTIAL TREATMENT REQUESTED
Item |
Amount |
Signing of definitive agreement (Signing Fee) |
£100,000 |
[*] |
[*] |
[*] |
[*] |
Clinical Trial Milestones: |
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[*] |
[*] |
[*] |
[*] |
Marketing Approval Milestones: |
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[*] |
[*] |
[*] |
[*] |
[*] |
[*] |
[*] |
[*] |
[*] |
[*] |
[*] |
[*] |
Revenue Milestones: |
|
A) [*]
|
[*] |
B) [*]
|
[*] |
C) [*]
|
[*] |
*For avoidance of doubt, each of A, B, and C above will only be paid once, but any of A, B, and C can be paid in the same year if multiple milestones are met in a single year. |
|
Royalty on Net Sales
Fee Income Royalty Rate
|
[*] [*] |
Annual maintenance fee |
|
2018 |
[*] |
2019 and 2020 |
[*] |
Each of 2021-2024 |
[*] |
2025 onwards |
[*] |
[*] = CONFIDENTIAL TREATMENT REQUESTED
Stargardts disease gene therapy development overview [*]
[*] = CONFIDENTIAL TREATMENT REQUESTED
The research and development projects into gene therapy for the treatment of ABCA4 gene therapy for Stargardts disease is supervised by Xxxxxxxxx Xxxxxx XxxXxxxx
OUI Project Number: [*]
OUI Project Title: ABCA4 gene therapy for Stargardts disease
AS WITNESS this agreement has been signed by the duly authorised representatives of the parties.
SIGNED for and on behalf of |
|
SIGNED for and on behalf of |
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OUI INNOVATION LIMITED: |
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NIGHTSTARX Limited: |
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Name: |
XX XXXX XXXXXX |
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Name: |
Xxxxx Xxxxxxx |
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Position: |
CHIEF OPERATING OFFICER |
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Position: |
CEO |
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OXFORD UNIVERSITY INNOVATION LTD |
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Signature: |
/s/ Xxxx Xxxxxx |
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Signature: |
/s/ Xxxxx Xxxxxxx |
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Date: |
12 OCT 2017 |
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Date: |
12 OCT 2017 |