text stringlengths 1 5.46k |
|---|
2. Design, clone, and generate candidate lentiviral vectors: |
i. Determine T cell specificity and ablation of receptors for other cell types |
ii. Perform optimization of transduction of T cells in peripheral blood (resting T cells) if necessary |
iii. Determine potential for immunogenicity |
3. Conduct biology activities to characterize the lentiviral vectors: |
i. Perform physical and functional titrations |
ii. Perform selectivity assessment in the presence of cell types other than T cells |
iii. Assess sensitivity to human complement and T cell transduction in human whole blood |
4. Conduct in vivo activities for this program: |
i. Profile in vivo vector potency (dose titration), vector biodistribution (if necessary), specificity/cell tropism, and sCART expansion through SWI019 switch |
ii. Determine efficacy in humanized mouse models with implanted solid tumors. In these models, human PBMCs will be engrafted on MHC knock-out mice and transduced in vivo with systemically delivered vectors. sCAR-T cells will be expanded with SWI019 and CD19-positive cells and retargeted against a selected solid tumor t... |
b) Engineering of packaging cell line to improve the vector attributes. |
1. Cell line engineering will attempt to reduce potential for immunogenicity of vectors. Calibr will determine impact of the following approaches: |
i. Knock out B2M and Knock in CD47 genes |
ii. Clone characterization and selection |
iii. Expansion of selected clones |
iv. Lentiviral vector generation employing selected clones |
2. Conduct biology activities to characterize the lentiviral vectors from (b): |
i. Perform physical and functional titrations |
ii. Assess immunogenicity of vectors in the presence of myeloid and other immune cells |
iii. Assess T cell transduction in human whole blood |
3. Conduct in vivo activities in humanized murine models: |
i. Profile of vector potency (dose titration), vector biodistribution/selectivity/cell tropism, and sCAR-T cell expansion through SWI019 switch dosing on similar model as above |
ii. Efficacy in humanized mouse models with implanted solid tumors. In this step, full reconstitution with a human immune system (including T, B, and myeloid cells) will be required to proof the advantages of the engineering strategies implemented. Therefore, humanized models with CD34+ HSC engrafted instead of PBMCs w... |
In situ sCAR-T platform development Discovery Activities |
Surrogate model PoC |
Engineering and generation of human vectors |
In vitro/vivo activities with human vectors |
Engineering of packaging cell line and vector generation |
In vitro/vivo activities with human vectors |
Lead nomination |
Estimated dates subject to change based on development. |
The proposed deliverable for this work plan will be a lead lentiviral vector sequence for in situ administration and a packaging cell line (R&D cell line) with biophysical and in vitro characterization data. Lead vectors will be characterized by preliminary PK/PD and efficacy data in murine models. Next steps of develo... |
Schedule 2.6.3: Key Personnel |
Travis Young, VP Biologics |
Eduardo Laborda, Associate Director Immuno-Oncology |
Alex Brooks, Director Clinical Operations |
Michael (Mickey) Emde, Principal Scientist Cell Manufacturing |
Schedule 7.6.4: Example Royalty Calculations |
An example of how royalties are calculated when the reduction in the royalty rate reduction in Section 7.6.4(a) of the Agreement applies is provided below for illustrative purposes only. Capitalized terms used but not defined in this Schedule 7.6.4 shall have the meaning set forth in the Agreement. |
For purposes of this example, assume the following: |
• The aggregate Net Sales of a Licensed Product in the Territory in a given Calendar Year are One Billion Four Hundred Million Dollars ($1,400,000,000). |
• Of the aggregate Net Sales, Three Hundred Fifty Million Dollars ($350,000,000) represent Net Sales in a country in the Territory where such Licensed Product is not claimed by a Valid Claim of any (i) Calibr Patent, (ii) any Joint Patent, or (iii) any Program Product Patent that was assigned to AbbVie by Calibr, in ea... |
• Calibr has not exercised its Cost-Sharing Option with respect to such Licensed Product so that the royalty rates in Section 7.6.1 apply. |
• AbbVie has not yet exercised the Platform Option. |
The royalties payable for such Licensed Product for the Calendar Year are determined as shown in the table that follows on the next page: |
[Schedule continues on next page] |
1 |
Royalty Tier |
Tier 1 -6% |
Tier 2 -8% |
Tier 3 -9% |
Totals |
1 For readability, certain amounts shown have been rounded to the nearest dollar and percentages shown have been rounded to the nearest half percent. |
7.6.4 - 2 |
Schedule 9.1.2: Form of Employee Non-Disclosure Agreement |
[See attached.] |
The California Institute for Biomedical Research CONFIDENTIALITY AND PROPRIETARY RIGHTS AGREEMENT |
1. Definitions. |
1.1 "Institute" means The California Institute for Biomedical Research or any of its employees, officers, directors, consultants, legal counsel and advisors. |
1.2 "Party" means the person signing this Agreement, who is an employee of Institute. |
1.3 "Invention" means inventions, discoveries, developments, concepts, and ideas, whether patentable, copyrightable or otherwise registrable, including but not limited to assays, targets, receptors, mask works, trademarks, trade names, logos, Internet domain names, URLs, service marks, processes, designs, techniques, d... |
1.4 "Trade Secret" means, without limitation, any document or information relating to the Institute's plans for research, development, manufacturing, engineering, new products, marketing and selling, business plans, proposed research or business affiliations, joint ventures or other collaborative or business relationsh... |
2. Purpose. In recognition of the need for Institute to protect its proprietary rights, and in consideration of the employment benefits to Party, and to memorialize and implement the previously existing oral agreements and implied agreement between Party and Institute, this Agreement is being signed by Party. |
3. Inventions. |
3.1 Disclosure. Except for items excluded pursuant to Section 3.3, Party shall disclose promptly to Institute each Invention, whether or not reduced to practice, which is conceived or learned by Party (either alone or jointly with others) during the term of his or her employment with Institute. Following any terminatio... |
3.2 Institute Property; Assignment. Except for items excluded pursuant to Section 3.3, Party acknowledges and agrees that all Inventions which are discovered, conceived, developed, made, produced or prepared by Party (alone or in conjunction with others) during the duration of Party's employment with Institute shall be... |
3.3 Exclusion Notice. Party has identified on Exhibit "A" attached hereto all Inventions, applicable to the business of Institute or relating in any way to Institute's business or demonstrably anticipated research and development or business, which were conceived, reduced to practice, created, derived, developed, or ma... |
3.4 Patents and Copyrights; Attorney-in-Fact. Both before and after termination of this Agreement (and with reasonable compensation to be paid by Institute to Party for any activities after termination), Party agrees to assist Institute to apply for, obtain and enforce patents on, and to apply for, obtain and enforce c... |
3.5 Maintenance of Records. Party agrees to keep and maintain adequate and current written records of all Inventions made by Party (solely or jointly with others) during the term of employment with Institute. The Records will be in the form of notes, sketches, drawings, and any other format that may be specified by Ins... |
4. Trade Secrets. |
4.1 Acknowledgment of Proprietary Interest. Party recognizes the proprietary interest of Institute in any Trade Secrets of Institute. Party acknowledges and agrees that any and all Trade Secrets of Institute shall be and are the property of Institute, including without limitation, any such Trade Secrets which may be de... |
4.2 Covenant Not to Divulge Trade Secrets. Party acknowledges and agrees that Institute is entitled to prevent the disclosure of Trade Secrets of Institute. As a portion of the consideration for the employment of Party and for the compensation being paid to Party by Institute, Party agrees at all times during the term ... |
4.3 Confidential Information of Others. Party will not disclose to the Institute, or use, or induce the Institute to use, any third party confidential, proprietary, or trade secret information, including but not limited to such information obtained from prior employers. Party represents and warrants that no property no... |
5. No Adverse Use. Party will not at any time during the term of employment or thereafter use Institute's Trade Secrets or Inventions in any manner which may directly or indirectly have an adverse effect upon Institute's business, nor will Party perform any acts which would tend to reduce Institute's proprietary value ... |
6. Return of Materials at Termination. In the event of any termination of Party's employment, Party will promptly deliver to Institute all materials (including, but not limited to, documents, drawings, models, apparatus, sketches, designs, laboratory notebooks, chemical and biological reagents (i.e., cell lines, vector... |
Institute and (c) written certification of Party's compliance with his or her obligations under this Section in the form attached hereto as Exhibit "C". |
7. No Conflict of Interest During Employment. For the duration of the employment relationship (and any consulting relationship), Party agrees to not pursue any activities, directly or indirectly, that creates a conflict of interest with Institute, including but not limited to competing with the existing or planned busi... |
8. Remedies Upon Breach. In the event of a breach by either party of the provisions in this Agreement, the non-breaching party shall be entitled, if it so elects, to obtain injunctive relief as specified by California Civil Procedure Code section 1281.8, to enjoin the breaching party from violating any of the terms of ... |
9. Exception. Notwithstanding the foregoing, if Party is required by a binding court or governmental order to disclose specified information, and Institute has been given reasonable advance written notice thereof to enable Institute to oppose the same, then Party may make such limited disclosures as are necessary to co... |
10. Applicable Provisions. The undersigned Party acknowledges and agrees that the foregoing provisions were understood and agreed to be applicable from the outset of Party's association with Institute, and that the foregoing provisions shall remain applicable for the duration of his or her employment with Institute, an... |
11. No Solicitation. Due to the confidential and proprietary nature of the Inventions and Trade Secret to which Party has been exposed, or which Party will learn or be exposed to, while at Institute, Party agrees that during the term of his or her employment with Institute and for a period of two (2) years thereafter, ... |
12. General Provisions. |
12.1 Entire Agreement. This Agreement constitutes the entire agreement between the parties with respect to its subject matter. This Agreement supersedes all prior or contemporaneous agreements or understandings, whether oral or written, on the same subjects, and this agreement cannot be modified unless such modificatio... |
12.2 Severability. In the event any provision of this Agreement is found unenforceable by an arbitrator or court of competent jurisdiction, that provision will be deemed modified to the extent necessary to allow enforceability of the provision as so limited. |
12.3 Applicable Law; Jurisdiction. This Agreement will be interpreted, construed and enforced under the laws of the State of California. Each of the parties irrevocably consents to the exclusive personal jurisdiction of the federal and state courts located in California, as applicable, for the resolution of any matter ... |
[Signatures Follow] |
I certify and acknowledge that I have carefully read all of the provisions of this Agreement and that I understand and will fully and faithfully comply with such provisions. |
DATED: |
DATED: |
EXHIBIT A |
Inventions Owned by Party Prior to Commencement of Employment (Attach and sign additional sheets if necessary) |
DATED: |
EXHIBIT B |
WRITTEN NOTIFICATION TO EMPLOYEE |
In accordance with California Labor Code § 2872, you are hereby notified that your Confidentiality and Invention Assignment Agreement does not require you to assign to the Company any Invention for which no equipment supplies, facility, or trade secret information of the Company was used and that was developed entirely... |
Following; is the text of California Labor Code § 2870: |
(a) Any provision in an employment agreement which provides that an employee shall assign, or offer to assign, any of his or her rights in an invention to his or her employer shall not apply to an invention that the employee developed entirely on his or her own time without using the employer's equipment supplies, faci... |
(1) Relate at the time of conception or reduction to practice of the invention to the employer's business, or actual or demonstrable anticipated research or development of the employer; or |
(2) Result from any work performed by the employee for the employer. |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.