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Cugene shall be responsible for and shall bear all costs and expenses necessary to perform its obligations set forth above, provided that (a) Item 5 set forth above will be performed at AbbVie's cost and expense and (b) FTE costs and out-of-pocket costs incurred by Cugene related to Items 7 and 10 set forth above are s... |
If the Parties cannot mutually agree to activities where mutual agreement is stated, the matter is to be resolved pursuant to the Agreement. |
III. PRE-CLINICAL ACTIVITIES |
A. GLP Toxicology |
For Initiation of Phase II Clinical Trials, 26-week GLP toxicity studies will be conducted in NHP and mice (unless indicated otherwise by FDA). The GLP Toxicology Protocol will be developed at and approved by the JGC, subject to Section 6.2.4(b) of the Agreement. |
Item Objectives Activities Timeline |
1 26-wk GLP NHP tox (Responsibility-Cugene) Final GLP Toxicology Protocol to be developed and approved at JGC, consistent with the preliminary specifications below. Start date to be determined by JGC based on Clinical Study progression: - Reports as MS Word, executed PDF versions, and SEND data sets for: - Study conduc... |
26-wk GLP Mouse tox (Responsibility-Cugene) Final GLP Toxicology Protocol to be developed and approved at JGC, consistent with the preliminary specifications below. Start date to be determined by JGC based on Clinical Study progression: - Reports as MS Word, executed PDF versions, and SEND data sets for: - Study conduc... |
2 Immunosafety Assays (Responsibility-Cugene) Assays to include ADCC activity, C1Q binding, and cytokine release from PBMC Available reports due within 30 days following the Effective Date |
3 PK method validation (human) (Responsibility-Cugene) Validation in compliance with most recent FDA/EMA guidance documents on Bioanalytical Method Validation Validation will be available before Initiation of Clinical Study and provided within 10 days of the receipt thereof |
4 ADA method validation (mice, NHP, human) (Responsibility-Cugene) Validation in compliance with most recent FDA/EMA guidance documents on Bioanalytical Method Validation Reports in mice and NHP will be available before Initiation of Clinical Study and reports in human will be provided within 10 days of the receipt the... |
5 Neutralizing Ab method validation (human) (Responsibility-Cugene) Validation in compliance with most recent FDA/EMA guidance documents on Bioanalytical Method Validation To be ready/validated for Phase Ib Clinical Trial |
B. Regulatory Affairs |
Regulatory Authority submissions and consultations |
US |
An IND in SLE is open to allow enrollment of US subjects into the FIH, SAD Phase Ia Clinical Trial in HV and ePOC MAD Phase Ib Clinical Trial in SLE subjects. If any Regulatory Authority interactions are needed/requested during the conduct of the Initial Development Plan and Budget (i.e., before the planned Phase II Cl... |
Item Regulatory Deliverable (Responsibility-Cugene) Activities Target Timeline |
1 Transfer responsibilities and obligations of CUG252 IND 152972 Parties to discuss date of transfer and consider any on-going activities that may impact timing of transfer (i.e., clinical data, non-clinical, CMC activities) From and after the License Option Effective Date |
2 If needed, submit FDA (Type C) meeting (or Request for Advice) to seek feedback on development program requirements (i.e., non-clinical, CMC, clinical) |
IV. DATA PACKAGE |
A. Clinical |
The Clinical Study report for the Phase Ia Clinical Trial and ePoC MAD Phase Ib Clinical Trial as described in the USA FDA IND 152972 and outlined in Section II.A: |
• Clinical disease activity(from Phase Ib Clinical Trial only) and safety information |
• Pharmacokinetic data |
• Immunogenicity (ADA) data |
• Biomarker data |
• Bioanlytical and validation reports for PK and ADA |
B. Non-clinical 6M GLP toxicology reports for activities in Section III |
• Audited final 6M GLP toxicology reports |
• Standard for Exchange of Nonclinical Data (SEND)-compliant reports and data sets for 6M toxicity study in mice (if required by FDA) and non-human primates conducted in accordance with Good Laboratory Practice |
C. Biomarker reports for activities in Section II.B |
• Immuno-monitoring: o Longitudinal numbers of major leukocyte populations (including eosinophils and monocytes) in SLE patients by differential CBC o Longitudinal numbers of blood T cells and Tregs, B, NK cells, in SLE patients by flow cytometry |
• Target engagement: o Longitudinal numbers of blood leukocytes in HV exposed to CUG252 or PBO (SAD) o Longitudinal quantitation of soluble IL-2R in HV exposed to CUG252 or PBO (SAD) o Longitudinal numbers of tregs/tconv in SLE Patients exposed to CUG252 or PBO (PoC) o Longitudinal quantitation of soluble IL-2R in SLE ... |
Biomarker samples (AbbVie understands and agrees that Cugene's current ICF does not contain the consent that is needed for Cugene to share the biomarker samples collected in Phase Ia Clinical Trials with AbbVie. Cugene will amend the IFC and study protocol to obtain such consent, but it may not be able to obtain suffic... |
• Availability of serum samples from consenting HVs exposed to CUG252 or PBO (SAD) |
• Availability of serum samples from consenting SLE patients exposed to CUG252 or PBO (MAD) |
• Availability of WB samples stored frozen in a proteomic stabilizer from consenting SLE patients at selective timepoints exposed to CUG252 or PBO (MAD) |
• Availability of cryopreserved PBMCs samples from consenting SLE patients at selective timepoints exposed to CUG252 or PBO (MAD) |
D. CMC Development Reports |
• All development reports as defined by activites listed in Section II.C Items 2, 3 and 6 and if the objectives outlined in Sections II.C Items 2 and 3 are achieved, development reports as defined by activities listed in Sections II.C Item 4, if any. |
• If the objectives outlined in Sections II.C Items 2 and 3 are achieved, for the lead lyophilized formulation, provide all available stability data from activities listed in Section II.C Item 4 at the time of delivery of the Final Data Package, including 2-8°C (up to 6 month), 25°C (up to 6 month), 40°C (up to 3 month... |
E. Regulatory Documentation |
• Provide access to FDA IND (no. 152972) and amendments to the IND in eCTD format, as well as correspondence to and from FDA. |
• Access to the IP, CRO agreements, data and reports and GxP quality agreements and audits that underly Cugene's updated disclosure schedules. |
SCHEDULE 2.3.4 |
PERMITTED ENTITIES |
Altasciences Company, Inc. |
Laboratory Corporation of America Holdings (Labcorp) |
IQVIA Holdings Inc. |
WuXi |
SCHEDULE 7.5 |
SAMPLE ROYALTY CALCULATION |
The calculation set forth in this Schedule 7.5 is for illustrative purposes only. |
• $2,000,000,000 in total Net Sales for a Licensed Product in the Territory (including Country A) (the "Total Net Sales"): |
o $1,000,000,000 in the 10% royalty tier (50% of Total Net Sales) |
o $1,000,000,000 in the 11% royalty tier (50% of Total Net Sales) |
• Out of the Total Net Sales, $500,000,000 in Net Sales for such Licensed Product in Country A (the "Country A Net Sales") where the royalty rates are subject to reduction pursuant to Section 7.5.3(b): |
o $250,000,000 in the 10% royalty tier (50% of Country A Net Sales) |
o $250,000,000 in the 11% royalty tier (50% of Country A Net Sales) |
• Royalties with respect to Total Net Sales excluding Country A Net Sales: |
o ($1,000,000,000 - $250,000,000) * .10 = $75,000,000 |
o ($1,000,000,000 - $250,000,000) * .11 = $82,500,000 |
o Total Royalties Excluding Country A = $157,500,000 |
• Royalties with respect to Country A Net Sales: |
o $250,000,000 * (.10)(.5) = $12,500,000 |
o $250,000,000 * (.11)(.5) = $13,750,000 |
o Total Royalties in Country A = $26,250,000 |
• Total Royalties payable with respect to Total Net Sales: |
o $157,500,000 + $26,250,000 = $183,750,000 |
SCHEDULE 9.6 |
FORM OF JOINT PRESS RELEASE |
AbbVie and Cugene Announce Collaboration in Autoimmune Diseases |
- AbbVie receives the option to license worldwide rights to CUG252 from Cugene, a clinical-stage and potential best-in-class Treg-selective IL-2 mutein, building on AbbVie's commitment to developing novel therapies in immunology - Cugene to complete a Phase 1a study in healthy volunteers and to conduct a Phase 1b study... |
NORTH CHICAGO, Ill. and WALTHAM, MA, [May XX, 2022] - AbbVie (NYSE: ABBV) and Cugene Inc., a clinical-stage biotechnology company focused on developing next-generation precision immunology and oncology medicines to treat autoimmune disease and cancer, today announced an exclusive worldwide license option agreement for ... |
Selective IL-2 muteins with the ability to safely restore immune system balance in patients with autoimmune and inflammatory disease have the potential to represent a major advancement in the standard of care. Cugene's lead candidate, CUG252, is an engineered IL-2 mutein designed to selectively activate and expand Treg... |
[["AbbVie is committed to developing novel therapies in immunology where unmet needs remain for patients living with complex autoimmune and inflammatory conditions," said Tom Hudson, MD, senior vice president, R&D, chief scientific officer, AbbVie. "Our partnership with Cugene is the latest in our efforts to develop an... |
"We are very pleased to partner with AbbVie, a global leader in the development and commercialization of innovative immunology therapies," said Luke Li, M.D., Chief Executive Officer of Cugene Inc. "AbbVie is an ideal partner for CUG252, with their commitment to R&D, deep therapeutic area expertise, and the global reso... |
[[Under the terms of the agreement, Cugene will receive an upfront payment of $48.5 million, and will also be eligible to receive development and regulatory milestones and a license option exercise payment if AbbVie exercises the option. In addition, Cugene may also receive commercialization and sales-based milestones ... |
About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology and ga... |
About Cugene Inc. Cugene is a clinical-stage biotechnology company focused on developing next-generation precision immunology and oncology medicines to treat autoimmune disease and cancer. Cugene is advancing an armamentarium of precision immune therapeutics with compelling target biology to improve patients' lives by ... |
Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking sta... |
### |
Contacts: |
Cugene Inc. Adam Daley Berry & Company Public Relations 212-253-8881 adaley@berrypr.com |
SCHEDULE 10.2.1(C) |
CUGENE PATENTS |
PART A: Owned Patents |
[Same patent table as earlier in the document] |
PART B: In-Licensed Patents |
Nil |
SCHEDULE 13.5.3 |
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 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 ADR. |
2. Within 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 such period, ea... |
3. No earlier than 28 days or later than 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 location other than the pri... |
4. At least seven 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 pro... |
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