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4. Within two (2) months after the United States BLA submission date for the Co-Promotion Product, the foregoing elements (items 1-3) must continue to be satisfied and Capsida must have: a. Completed hiring of all sales representatives allocated to Capsida in the then-current ALS Commercialization Plan provided by AbbV... |
5. At least two (2) months prior to the date established by FDA pursuant to the Prescription Drug User Fee Act for completing the review of the BLA for the Co-Promotion Product in the United States, the foregoing elements (items 1-4) must continue to be satisfied and Capsida must have: a. Completed training and testing... |
6. From and after receipt of Regulatory Approval of the BLA for the Co-Promotion Product in the United States, the foregoing elements (items 1-5) must continue to be satisfied and Capsida must: a. Conduct all co-promotion activities with respect to the Co-Promotion Products in the United States in accordance with the t... |
B. Consequences of Non-Compliance with Co-Promotion Readiness. If AbbVie reasonably determines pursuant to Section 6.3.3 that Capsida is not in compliance with, or is not reasonably likely to comply with, the Co-Promotion Readiness Plan, AbbVie shall deliver written notice of such determination to Capsida (each, a "Non... |
1. If AbbVie reasonably determines that Capsida has not satisfied or is not reasonably likely to satisfy each of the elements of the Co-Promotion Readiness Plan identified in A.3.a, A.3.c (with respect to hiring sales trainers and legal, regulatory and ethics/compliance sales support), A.3.d, and A.5.a (such elements, ... |
2. If AbbVie reasonably determines that Capsida has satisfied each of the Co-Promotion Compliance Readiness Elements as of the required date but has not satisfied or is not reasonably likely to satisfy any of the other elements of the Co-Promotion Readiness Plan as of the required date, AbbVie shall have the right to r... |
a. If AbbVie reasonably determines that Capsida has not satisfied or is not reasonably likely to satisfy element A.3.c (with respect to first- and higher-level managers for the sales force) or element A.4.a of the Co-Promotion Readiness Plan as of the required date, but Capsida has hired in excess of fifty percent (50%... |
3. If AbbVie reasonably determines that Capsida has not satisfied or is not reasonably likely to satisfy (a) any element of the Co-Promotion Readiness Plan (other than element A.3.c (with respect to first- and higher-level managers for the sales force), element A.4.a or the Co-Promotion Compliance Readiness Elements) o... |
1 |
SCHEDULE 11.5A |
Press Release |
2 |
Capsida Biotherapeutics Debuts with $140 Million of Capital |
– Versant, Westlake Village BioPartners launch next-generation gene therapy company with $50 million Series A – |
–Collaboration with AbbVie provides $90 million in up front and equity investment capital to create tissue-targeted gene therapies for three CNS disease targets – |
THOUSAND OAKS, Calif., April XX, 2021 – Versant Ventures and Westlake Village BioPartners today announced the emergence from stealth mode of Capsida Biotherapeutics Inc., a biotechnology company using an adeno-associated virus (AAV) engineering and cargo development platform to develop tissue-targeted gene therapies fo... |
"Our high-throughput AAV engineering platform is designed to identify differentiated capsids and cargos that will successfully deliver gene therapies with superior cell and tissue targeting and safety profiles than current-generation products in both CNS and non-CNS diseases," said Robert Cuddihy, M.D., chief executive... |
A next-generation AAV and cargo platform |
Although current gene therapy approaches have shown dramatic efficacy in several rare diseases, the medicines are hindered by imprecise targeting, an inability to transduce a number of cell types and tissues effectively, and safety liabilities. Specifically, most current-generation approaches use naturally occurring se... |
As a result, many monogenetic and sporadic neurodegenerative disorders yet remain unaddressed by this therapeutic modality. |
Capsida is addressing these concerns with its AAV engineering platform that generates capsids optimized to target specific tissue types and limits transduction of tissues and cell types that are not relevant to the target disease, allowing for improved efficacy and safety. In addition, Capsida is developing proprietary... |
The platform originated from groundbreaking research in the laboratory of Viviana Gradinaru, Ph.D., Professor of Neuroscience and Biological Engineering, Heritage Medical Research Institute Investigator, and Director of the Center for Molecular and Cellular Neuroscience at the Tianqiao and Chrissy Chen Institute for Ne... |
The company's engineered capsids have demonstrated markedly enhanced tissue tropism for neurons versus astrocytes, glia, and other CNS cell types, thus demonstrating potential to unlock treatments for disorders requiring neuronal transduction that exceeds the performance of first-generation AAV9-based therapies. |
"With our long-standing track record in the gene therapy space, it is gratifying to help launch Capsida, which is taking a novel approach to developing genetic medicines," said Clare Ozawa, Ph.D., managing director at Versant and a Capsida board member. |
Collaboration with AbbVie |
Capsida's newly announced collaboration with AbbVie will use the biotech's platform to identify and advance clinically translatable capsids paired with an innovative therapeutic approach from AbbVie to create tissue-targeted gene therapies for three CNS disease targets. |
Under the terms of the agreement, Capsida will receive $80 million up front in cash and a $10 million equity investment. For targets one and two, upon AbbVie exercising its option, Capsida is eligible to receive $530 million in option and development milestone payments excluding commercial milestone payments. Capsida i... |
For the third disease target, upon AbbVie exercising its option, Capsida will have the right to develop through human proof-of-concept, and AbbVie would lead late-stage development and commercialization. Following human proof-of-concept, the parties would enter into a 50/50 cost:profit share with Capsida having the opt... |
For all three programs, Capsida will lead capsid discovery efforts using its high throughput AAV engineering and screening platform and AbbVie will contribute innovative therapeutic approaches. Capsida will also be responsible for process development and early clinical manufacturing of all programs. |
"We are excited to enter this licensing agreement with Capsida. By combining Capsida's deep understanding of the structure-function relationship of AAV biology with AbbVie's innovative cargo therapeutic technologies, we will strive to develop highly effective and transformative gene therapies for patients with devastat... |
Capsida operating plans |
Capsida's initial internal preclinical programs center on neurodevelopmental and neurodegenerative disorders, areas in which gene therapies have yet to gain significant traction due to the difficulties of targeting the brain. Based on progress to date, Capsida expects to start IND-enabling work on its first development... |
In addition to continuing preclinical work on its lead assets, the company plans to use proceeds from its $50 million Series A financing to open its state-of-the-art manufacturing facility this year and advance its platform into non-CNS disorders. |
The company is operating from its site in Thousand Oaks, California. |
"Capsida is another example of the growing biotech hub in the Greater Los Angeles area," said Beth Seidenberg, M.D., founding managing director at Westlake Village BioPartners and a Capsida board member. "Westlake Village BioPartners is proud to be catalyzing this growth. Capsida is led by an outstanding team of execut... |
With the anchor investment from Versant and Westlake, and the collaboration with AbbVie, Capsida plans to expand its 50-member team to about 100 scientists this year. To capture the expanding opportunities in the field of gene therapy, Capsida will pursue additional strategic opportunities in parallel with financial in... |
About Capsida Biotherapeutics |
Capsida Biotherapeutics Inc. is developing tissue-targeted gene therapies using its biologically driven, high-throughput adeno-associated virus (AAV) engineering and proprietary cargo development platform. As a fully integrated gene therapy company, Capsida is combining its differentiated AAV engineering and screening ... |
About Versant Ventures |
Versant Ventures is a leading healthcare venture capital firm committed to helping exceptional entrepreneurs build the next generation of great companies. The firm's emphasis is on biotechnology companies that are discovering and developing novel therapeutics. With $4.2 billion under management and offices in the U.S.,... |
About Westlake Village BioPartners |
Westlake Village BioPartners is a Los Angeles area-based venture capital firm focused on incubating and building life sciences companies with entrepreneurs who have the potential to bring transformative therapies to patients. Westlake manages more early stage venture capital solely from the greater Los Angeles area tha... |
Media Contacts: |
Versant Steve Edelson (415) 801-8088 sedelson@versantventures.com |
Westlake Village BioPartners Greig Communications, Inc. Kathy Vincent (310) 403-8951 kathy@greigcommunications.com |
# # # |
SCHEDULE 11.5B |
AbbVie and Capsida Biotherapeutics Expand Strategic Collaboration to Develop Targeted Genetic Medicines for Eye Diseases with High Unmet Need |
- Partnership Combines AbbVie's extensive capabilities with Capsida's novel adeno-associated virus (AAV) engineering platform - Builds upon the neurodegenerative disease partnership announced in 2021 |
NORTH CHICAGO, Ill. and THOUSAND OAKS, Calif. – February 23, 2023 – AbbVie (NYSE: ABBV) and Capsida Biotherapeutics Inc. ("Capsida") today announced an expanded strategic collaboration to develop genetic medicines for eye diseases with high unmet need. AbbVie's extensive capabilities will be paired with Capsida's novel... |
"This expanded collaboration with Capsida has the potential to develop transformative therapies for patients with serious eye diseases," said Jonathon Sedgwick, Ph.D., vice president and global head of discovery research, AbbVie. "In pursuing the promise of genetic medicine-based therapeutics, AbbVie continues to expan... |
"AbbVie has been an excellent partner, and we are excited to expand our collaboration into ophthalmology with the world leader in this therapeutic area," said Peter Anastasiou, chief executive officer of Capsida. "Combining AbbVie's expertise in eye disease drug development and commercialization with Capsida's fully in... |
Under the terms of the expanded agreement, Capsida will receive $70 million, consisting of upfront payments and a potential equity investment. For the three programs, Capsida may be eligible to receive up to $595 million in option fees and research and development milestones, with potential for further commercial miles... |
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 Capsida Biotherapeutics Capsida Biotherapeutics is a fully integrated next-generation gene therapy platform company. Capsida's approach unlocks the potential to treat both rare and common diseases across all ages. We create customized therapies that selectively target specific organ systems and simultaneously lim... |
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: |
For AbbVie |
Media Frank Benenati (847) 938-8745 frank.benenati@abbvie.com |
Investors Liz Shea (847) 935-2211 liz.shea@abbvie.com |
For Capsida Kathy Vincent Greig Communications, Inc. kathy@greigcommunications.com |
1 |
SCHEDULE 12.2 |
Initial Neurology Disclosure Schedule |
1 |
SCHEDULE 12.3 |
Initial Ophthalmology Disclosure Schedule |
Intentionally left blank. |
1 |
SCHEDULE 12.2.1 |
A: Existing In-License Agreements as of the Original Agreement Effective Date |
1. License Agreement by and Between Capsida and Caltech dated August 5, 2019 and as amended September 1, 2020 |
2. Life Technologies Cell Line License Agreement by and between Capsida and Life Technologies Corp. dated February 10, 2021. |
3. License Agreement by and between Capsida and Advec Inc dated July 8, 2020. |
B: Future Capsida In-License Agreements for Neurology Program |
1 |
SCHEDULE 12.2.4 |
Existing NP Patents |
[Table containing patent information with columns: BR Ref, Serial Number, Filing Date, Title, Owner, License Type, Status] |
[The table contains multiple patents related to adeno-associated viruses with various filing dates, mostly owned by Caltech with exclusive licenses to Capsida] |
1 |
SCHEDULE 12.3.1 |
A: Existing In-License Agreements as of the Original Agreement Effective Date |
License Agreement by and Between Capsida and Caltech dated August 5, 2019 and as amended September 1, 2020 |
Life Technologies Cell Line License Agreement by and between Capsida and Life Technologies Corp. dated February 10, 2021. |
License Agreement by and between Capsida and Advec Inc dated July 8, 2020. |
B: Future Capsida In-License Agreements for Ophthalmology Program |
SCHEDULE 12.3.4 |
Existing OP Patents |
[Same as 12.2.4 as of the Effective Date] |
1 |
SCHEDULE 15.6.3 |
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... |
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 e... |
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... |
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