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• 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... |
d) a brief in support of such Party's proposed rulings and remedies; provided that the brief shall not exceed 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 consecutive days and shall be governed by the following rules: |
a) Each Party shall be entitled to five hours of hearing time to present its case. The Neutral shall determine whether each Party has had the five 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-examination... |
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 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 pages. This page limitation shall apply... |
7. The Neutral shall rule on each disputed issue within 14 days following completion of the hearing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one of the Parties on each disputed issue but may adopt one Party's proposed rulings and remedies on some issues and the other Party's proposed r... |
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 Party on all disputed issues in the ADR, the losing Party shall pay 100% of such fees and expenses. |
b) If the Neutral rules in favor of one 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 relati... |
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 Copy |
88878677_21 |
DEVELOPMENT, EXCLUSIVITY AND OPTION PRODUCTS AGREEMENT |
By and between |
COLLPLANT LTD. |
AND |
ALLERGAN INDUSTRIE S.A.S. |
AND |
ALLERGAN PHARMACEUTICALS INTERNATIONAL LIMITED |
TABLE OF CONTENTS |
Article 1 - DEFINITIONS .............................................................................................................. 2 |
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