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1. minimum of 4 intravenous dose levels (with a minimum of 6 subjects receiving active drug and a minimum of 2 subjects receiving placebo); and |
2. minimum of 2 subcutaneous dose levels (matching the same intravenous dose level, and with a minimum of 6 subjects receiving active drug and a minimum of 3 receiving placebo). |
b. Multi-ascending dose study assessing the safety, tolerability, and pharmacokinetics of multiple doses of intravenous or subcutaneous of a Licensed Antibody in healthy volunteers (with a minimum of 9 subjects receiving active drug and a minimum of 3 receiving placebo in each treatment arm). |
Schedule 6.3.2 Biomarker Milestone Criteria |
Statistically significant (p< 0.1) demonstrated reduction in a target cell (e.g. ILC2 or eosinophil) numbers or changes in soluble circulating SCF (SCF165) levels versus pre-dose baseline that is reflecting a dose dependent target engagement of SCF248 in healthy volunteers (unless a statistically significant difference... |
Schedule 6.3.3 At Initiation of Phase I/IB Milestone Criteria |
A protocol for the Phase I/IB Trial has been mutually agreed by the Parties and contains the following minimum criteria: |
a. A placebo-controlled, double-blind randomized proof-of-concept study of a Licensed Antibody in adult patients (18-75 years) with dermatologist-confirmed diagnosis of atopic dermatitis; |
b. The subjects must have moderate to severe atopic dermatitis; |
c. A Licensed Antibody and placebo would be administered by intravenous or subcutaneous dosing in a parallel design, a minimum of 24 subjects per group in the Licensed Antibody arms and in the placebo arm (a minimum of 72 subjects in total) for a minimum of 24 weeks; and |
d. The Phase I/IB Trial would evaluate a minimum of two doses of the Licensed Antibody that will include an anticipated effective dose based on predictive efficacious dose, the target engagement, other biomarker data and the maximum safe dose allowed for the Licensed Antibody. |
Schedule 10.2 Disclosure Schedule |
Unless the context otherwise requires, all capitalized terms used in this Disclosure Schedule and not defined herein shall have the respective meanings assigned to them in the Agreement. |
This Disclosure Schedule has been arranged, for purposes of convenience only, as separate parts corresponding to the sections of Section 10.2 of the Agreement; provided, however, that any information disclosed herein under any section number shall be deemed to be disclosed and incorporated in any other section of the A... |
Section 10.2.1 (Existing Patents) |
Owned Patents |
Docket No. Country Application No. Application Date Title |
OPSL-001/00US United States of America 62/900,927 9/16/2019 ANTI-STEM CELL FACTOR ANTIBODIES AND METHODS OF USE THEREOF |
OPSL-001/01WO Patent Cooperation Treaty PCT/US2020/050973 9/16/2020 ANTI-STEM CELL FACTOR ANTIBODIES AND METHODS OF USE THEREOF |
OPSL-001/01US United States of America 17/022,465 9/16/2020 ANTI-STEM CELL FACTOR ANTIBODIES AND METHODS OF USE THEREOF |
OPSL-001/01TW Taiwan 109131936 9/16/2020 ANTI-STEM CELL FACTOR ANTIBODIES AND METHODS OF USE THEREOF |
OPSL-001/01AR Argentina 20200102566 9/16/2020 ANTI-STEM CELL FACTOR ANTIBODIES AND METHODS OF USE THEREOF |
OPSL-001/01UY Uruguay 38883 9/16/2020 ANTI-STEM CELL FACTOR ANTIBODIES AND METHODS OF USE THEREOF |
OPSL-001/02WO Patent Cooperation Treaty PCT/US2020/050974 9/16/2020 ANTI-STEM CELL FACTOR ANTIBODIES AND METHODS OF USE THEREOF IN RENAL DISEASE |
In-Licensed Patents |
Reference is made to Schedule 1.150 (University Patent Rights – in-licensed). |
Abzena Agreement: Patents and patent applications derived from WO2006082406 Human Antibodies and Proteins comprising the following national phase applications: |
Europe EP1844074 |
Canada CA2596833 |
Japan JP2008528668 |
India 546/DELNP/2007 |
China 200680004068 |
Hong Kong 08103899.8 |
Australia AU2006210724 |
South Korea KR20070107739 |
USA US2008206239 |
Section 10.2.3 |
NIH Grant Number: 1R41DK112426-01 FAIN: R41DK112426 ("Project Title: Therapeutic Mabs for Chronic Kidney Disease"), solely with respect to customary rights retained by the federal government of the United States or any agency thereof, as set forth therein. |
UOFM License Agreement, solely with respect to customary rights retained by UM on behalf of the federal government of the United States or any agency thereof, as set forth therein. |
Section 10.2.14 |
Certain Licensor Know-How was disclosed in the context of research performed at the University of Michigan, as and to the extent described in that certain Assignment Agreement by and among UM, Opsidio and GenScript USA Inc., the form of which has been disclosed and provided to AbbVie as of the Effective Date. |
Section 10.2.18 |
There is an annual amount of $3,500 due under the Biological Materials License between the National Institute of Health (NIH) and Licensor dated March 7, 2018. |
Schedule 13.7.3 ADR Procedures |
Any Dispute referred to ADR under this Agreement shall be resolved as follows: |
1. To begin an ADR proceeding, a Party shall provide written notice to the other Party of the Dispute to be resolved by ADR. Within fourteen (14) days after its receipt of such notice, the other Party may, by written notice to the Party initiating the arbitration, add additional issues to be resolved within the same AD... |
2. Within twenty-one (21) days following the initiation of the ADR proceeding, the Parties shall select a mutually acceptable independent, impartial and conflicts-free neutral to preside in the resolution of all issues in this ADR proceeding. If the Parties are unable to agree on a mutually acceptable neutral within su... |
3. No earlier than twenty-eight (28) days or later than fifty-six (56) days after selection, the Neutral shall hold a hearing to resolve each of the issues identified by the Parties. The ADR proceeding shall take place at a location agreed upon by the Parties. If the Parties cannot agree, the Neutral shall designate a ... |
4. At least seven (7) days prior to the hearing, each Party shall submit the following to the other Party and the Neutral: |
(a) a copy of all exhibits on which such Party intends to rely in any oral or written presentation to the Neutral; |
(b) a list of any witnesses such Party intends to call at the hearing, and a short summary of the anticipated testimony of each witness; |
(c) a proposed ruling on each issue to be resolved, together with a request for a specific damage award or other remedy for each issue. The proposed ruling shall not contain any recitation of the facts or any legal arguments, and the proposed remedy shall not include any punitive damages. The proposed ruling and the pr... |
(d) a brief in support of such Party's proposed rulings and remedies; provided, that the brief shall not exceed twenty (20) pages. This page limitation shall apply regardless of the number of issues raised in the ADR proceeding. |
Except as expressly set forth in subparagraphs 4(a) - 4(d), no discovery shall be required or permitted by any means, including depositions, interrogatories, requests for admissions, or production of documents. |
5. The hearing shall be conducted on two (2) consecutive days and shall be governed by the following rules: |
(a) Each Party shall be entitled to five (5) hours of hearing time to present its case. The Neutral shall determine whether each Party has had the five (5) hours to which it is entitled. |
(b) Each Party shall be entitled, but not required, to make an opening statement, to present regular and rebuttal testimony, documents, or other evidence, to cross-examine witnesses, and to make a closing argument. Cross-examination of witnesses shall occur immediately after their direct testimony, and cross-examinatio... |
(c) The Party initiating the ADR shall begin the hearing and, if it chooses to make an opening statement, shall address therein not only issues it raised but also any issues raised by the responding Party. The responding Party, if it chooses to make an opening statement, also shall address all issues raised in the ADR.... |
(d) Except when testifying, witnesses shall be excluded from the hearing until closing arguments. |
(e) Settlement negotiations, including any statements made therein, shall not be admissible under any circumstances. Affidavits prepared for purposes of the ADR hearing also shall not be admissible. As to all other matters, the Neutral shall have sole discretion regarding the admissibility of any evidence. |
6. Within seven (7) days following completion of the hearing, each Party may submit to the other Party and the Neutral a post-hearing brief in support of its proposed rulings and remedies; provided, that such brief shall not contain or discuss any new evidence and shall not exceed ten (10) pages. This page limitation s... |
7. The Neutral shall rule on each disputed issue within fourteen (14) days following completion of the hearing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one (1) of the Parties on each disputed issue but may adopt one (1) Party's proposed rulings and remedies on some issues and the other... |
8. The Neutral shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows: |
(a) If the Neutral rules in favor of one (1) Party on all disputed issues in the ADR, the losing Party shall pay one hundred percent (100%) of such fees and expenses. |
(b) If the Neutral rules in favor of one (1) Party on some issues and the other Party on other issues, the Neutral shall issue with the rulings a written determination as to how such fees and expenses shall be allocated between the Parties. The Neutral shall allocate fees and expenses in a way that bears a reasonable r... |
9. The rulings of the Neutral and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in any court having jurisdiction. |
10. Except as provided in paragraph 9 or as required by law, the existence of the Dispute, any settlement negotiations, the ADR proceeding, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed to be Confidential Information of both Parties. The Neutral shall hav... |
11. All ADR proceedings shall be conducted in the English language. |
12. Each Party shall have the right to be represented by counsel in all aspects of any ADR proceeding. |
EXECUTION VERSION CONFIDENTIAL |
EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT between OSE IMMUNOTHERAPEUTICS SA and ALLERGAN CAPITAL S.À.R.L. Dated as of February 27, 2024 |
TABLE OF CONTENTS |
ARTICLE 1 DEFINITIONS |
ARTICLE 2 TRANSITION GOVERNANCE |
2.1 Transition Governance Committee |
2.2 General Provisions Applicable to the JGC |
ARTICLE 3 DEVELOPMENT AND REGULATORY |
3.1 Transition and Development Activities |
3.2 Development Activities and Costs |
3.3 Subcontracting |
3.4 Supply, Manufacture and Cost of Licensed Antibodies or Licensed Products |
3.5 Records |
3.6 Regulatory Matters |
3.7 AbbVie Diligence Obligations |
ARTICLE 4 COMMERCIALIZATION |
4.1 In General |
4.2 Statements and Compliance with Applicable Law |
4.3 Booking of Sales; Distribution |
ARTICLE 5 GRANT OF RIGHTS |
5.1 Grants to AbbVie |
5.2 Sublicenses |
5.3 Distributorships |
5.4 No Other Rights |
5.5 OSE Proposed Future In-License Agreements |
ARTICLE 6 PAYMENTS AND RECORDS |
6.1 Upfront Payment |
6.2 Development Milestones |
6.3 Regulatory Milestones |
6.4 Sales-Based Milestones |
6.5 Royalties |
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