Dataset Viewer
text
stringlengths 1
5.46k
|
|---|
AbbVie Global Enterprises Ltd. 4th Floor, Washington House 16 Church Street Hamilton HM11, Bermuda abbvie.com |
20-Dec-23 |
Alpine Immune Sciences Inc. 188 E Blaine St Suite 200 Seattle, WA 98102 United States Attention: Paul Rickey, CFO |
Re: The Option and License Agreement between Alpine Immune Sciences Inc. ("Alpine" or "Licensor") and AbbVie Global Enterprises Ltd. (as assignee of AbbVie Ireland Unlimited Company) ("AbbVie"), made and entered into as of June 17, 2020, as amended by that certain letter dated April 12, 2022 (the "Agreement") |
To Whom it May Concern: |
This letter serves to memorialize the amendment of certain terms of the Agreement as set forth herein. |
1. Modification of the Option Exercise Fee. The Parties agree that Section 6.4 (Option Exercise Fee) is hereby deleted and replaced in its entirety with the following: |
Option Exercise Fee. Within thirty (30) days after the Option Effective Date, AbbVie shall pay Licensor a one-time payment of Ten Million Dollars ($10,000,000) (the "Option Exercise Fee"). |
2. Modification of Certain Payments. The Parties agree that, notwithstanding anything to the contrary in the Agreement: |
a. the amount of each payment payable by AbbVie to Licensor under each of Section 6.2 (Development Milestones by Licensor), Section 6.3 (Development Milestones by AbbVie), Section 6.5 (Sales-Based Milestones) or Section 6.6 (Royalties) is hereby reduced to seventy-five percent (75%) of the amount written in Section 6.2 (Development Milestones by Licensor), Section 6.3 (Development Milestones by AbbVie), Section 6.5 (Sales-Based Milestones) or Section 6.6 (Royalties), as applicable; |
accordingly, for purposes of example, the amount payable by AbbVie to Licensor under Section 6.3 (Development Milestones by AbbVie) for the occurrence of the first development milestone (i.e., Initiation of the first Phase III for a Licensed Product for an Indication other than aGVHD) shall be $30,000,000 not $40,000,000 as written; and |
b. the third development milestone in Section 6.2 (Development Milestones by Licensor) is in its entirety hereby deleted from the Agreement in its entirety and will not be payable by AbbVie. |
3. New Analysis. Alpine will stop enrollment of any new patients in the Phase II SLE Clinical Study within thirty (30) days of the date of this letter and will conduct a final analysis after the last patient enrolled in the Phase II SLE Clinical Study as of the date of this letter has completed the study protocol (the "New Analysis"). An approximate timeline for the New Analysis is set forth in Exhibit B. Alpine agrees to perform a test or preliminary analysis prior to performing the New Analysis, no later than 4 months before planned final analysis. |
4. Data Package. Based on the New Analysis, Alpine agrees to provide AbbVie with a data package containing at least the elements set forth in Exhibit B to this letter, including without limitation all patient level data in a format reasonably acceptable to AbbVie New Analysis Data Package. a complete New Analysis Data Packa New Analysis Data Package Delivery Date. Data Package, request access to all Information previously generated in the performance of the activities set forth in the Development Plan (which Alpine shall provide to AbbVie as soon as practicable following such request), and to ask questions of and receive timely answers from Alpine related thereto. Alpine agrees that its provision o |
5. AbbVie Review. AbbVie may, in its sole discretion, exercise the Option by providing written notice of such to Alpine no later than ninety (90) days after the New Analysis Data Package Delivery Date (such period, New Analysis Review Period. notice to Alpine that it does not believe the New Analysis Data Package provided contains the required information then (a) the New Analysis Review Period shall be tolled, (b) Alpine shall provide to AbbVie an updated New Analysis Data Package containing the required information as promptly as practicable, and (c) the New Analysis Review Period shall continue following the date of delivery of the updated New Analysis Data Package containing the required information; provided that if Licensor in good faith believes that the New Analysis Data Package is complete after the first extension, then the dispute shall be handled as set forth in Section 13.7 (Dispute Resolution). If the resolution of such dispute is that the New Analysis Data Package is complete, the New Analysis Data Package shall be deemed to be complete, and the New Analysis Review Period shall expire on the later of: (i) the expiration date of the original New Analysis Review Period, as tolled under clause (a) of this Paragraph 5 above, and (ii) sixty (60) days following the date that the Parties receive written notice of such decision. |
6. Non-Exercise of Option. In the event that AbbVie does not exercise the Option during the New Analysis Review Period, the Agreement will terminate without any action of either Party on the first day following the New Analysis Review Period pursuant to Section 12.1(a), with consequences as set forth in the Agreement. |
7. Public Announcements. Notwithstanding Section 9.5 of the Agreement, Alpine shall not issue any other written co Applicable Law or the rules of a stock exchange on which its securities are listed. |
8. Miscellaneous. The Agreement shall remain in full force and effect except as expressly modified by this letter. This letter constitutes the entire understanding between the Parties with respect to the amendment of the Agreement, and supersedes all prior understandings, both written and oral, between the Parties with respect thereto. |
Capitalized terms used in this letter have the meanings set forth in the Agreement. Unless otherwise specified, section references in this letter refer to the applicable section in the Agreement. This letter will be effective upon execution by each of the parties. |
Please countersign this letter below and return a copy to AbbVie. If you have any questions regarding this letter, please contact John Larson, Senior Director, Alliance Management, at (847) 935-8190. |
Sincerely, |
AbbVie Global Enterprises Ltd. Name: Title: |
Agreed: |
Alpine Immune Sciences Inc. Name: Paul Rickey Title: CFO |
Exhibit A |
Illustrative Timeline for Final Analysis |
Exhibit B |
New Analysis Data Package |
The New Analysis Data Package shall include all Clinical Data, including: ALPN-101 Clinical Data, Regulatory Documentation and other Information resulting from the Development Activities or the aGVHD Clinical Study conducted on or prior to (i) in the case of Clinical Information (as defined below), the New Analysis Data Package Trigger Event and (ii) in the case of all other Information, the delivery of the New Analysis Data Package, including the following: |
Clinical Studies: All the clinical information for Clinical Study AO3 and AO3a conducted under the Development Plan and the Clinical Information |
Protocol and all amendments o CRF/aCRF, SAP o All SDTM datasets and specs o All ADaM datasets and specs, production SAS programs, QC documentation and SAS programs o All TFLs, production SAS programs, QC documentation and SAS programs |
Dose recommendation along with the justification, if applicable |
Aggregate safety data, safety reports and any safety monitoring committee minutes, recommendations, and charters |
Study conduct metrics (including patient enrollment data, site activation, data collection & cleaning metrics, site monitoring plan) CSR (after opt-in) |
Clinical PK, Immunogenicity, and Biomarker data: Summary and individual subject-level data for PK, PD (including target engagement and downstream PD biomarkers as indicated below), anti-drug antibodies, and neutralizing antibodies. |
Target Saturation (combined CD28/ICOS) |
Change in SLE biomarkers (e.g., total IgM and IgG, Complement C3/C4, ANA and anti-dsDNA) |
Change in peripheral blood numbers and frequencies of T cells, B cells, NK cells and Monocytes (Trucount TBNKMo assay) |
Change in peripheral blood numbers and/or frequency of peripheral blood T and B cell subpopulations by immunophenotyping |
Change in soluble CD28 and ICOS and their ligands |
Additional exploratory biomarker analysis to inform on PD and MOA as deemed necessary by the Joint Governance Committee |
Biomarker methods reports and summaries, including validation reports |
Non-Clinical: |
Nonclinical and Bioanalytical reports |
Bioanalytical methods reports and summaries, including validation reports for quantitation of ALPN-101, ADA and nAb (as appropriate) |
Standard for Exchange of Nonclinical Data (SEND)-compliant toxicology reports and data sets for 6M toxicity study, resulting from the Initial Development Activities conducted in accordance with Good Laboratory Practice |
CMC: |
Development reports (Cell line, Formulation, Process) for both Process A and Process B: |
Reports for completed activities for cell line development to include: Cell line development including plasmid construction and history of the parental cell line, Clonal cell line generation, Cell line screening and selection, MCB production and characterization, MCB Certificate of Analysis, Executed batch record for MCB |
Viral clearance study report (or study data collected to date if report is not fully generated) |
Reports from DS/DP manufacturing process development experiments demonstrating conditions/resins/parameter evaluation leading to the Phase I/IIGMP process |
Reports from manufacture and testing of Non-GMP batches (including, but not limited to, scale up batches, small scale engineering batches, at scale engineering batches, and GLP toxicology batches) |
Reports from DS/DP hold-time studies to support at-scale process holds and excursions |
Reports covering reference standard manufacture |
Reports from DS and DP formulation development experiments including studies at stressed storage conditions that led to the selected Phase IIa/IIb DS and DP formulation and container closure |
Manufacturing campaign reports, summaries, and investigations/deviations; to include release data, stability, and CofAs for each DS and DP GMP batch |
Comparability reports to cover manufacturing/formulation/tox material changes |
Analytical reports for both Process A and Process B materials: |
Reports including identification and qualification of impurities (process-related or product-related impurities) |
Reports covering reference standard characterization, qualification and stability |
Completed report(s) documenting characterization results to include physicochemical, biophysical, and biological tests sufficient to characterize the primary structure, secondary structure, tertiary structure, aggregates and fragments, other degradation pathways (e.g., oxidation, deamination), post-translational modifications, purity, product variants, product-related impurities, glycosylation profile, CD28-ICOS binding activity, CD28-ICOS inhibition activity, and Fc receptor binding properties of ALPN-101. |
SOPs and reports for establishment of QC test methods, to include: test method SOPs, test method development reports, test method validation reports, method robustness assessment |
Product-specific Host Cell Protein (HCP) method development and/or qualification reports |
Reports and documentation supporting establishment of the cell-based bioassay (process A and B), to include: method development and validation reports of the cell-based bioassay |
Reports and documentation supporting establishment of the validated, stability-indicating CD28-ICOS inhibition assay for potency measurement, to include: Method development and validation reports |
Stability study reports |
All CRO agreements, data and reports and GxP quality agreements and audits. |
Regulatory Documentation o Pre-IND FDA Briefing Package, preliminary comments, minutes o Briefing packages, preliminary comments, minutes for all other FDA consultations o Briefing Packages, presentations, preliminary queries, minutes of consultations with global health authorities. o IND/ CTA submissions and approvals o All IND module 3 documentation and all Quality IMPD documentation submitted to health authorities in support of clinical trials o FDA and global health authority correspondences o Ad-hoc Pre-clinical, Clinical, CMC submissions including CSRs, SAP, module 3 updates |
99450416_50 |
Execution Version |
CO-DEVELOPMENT AND LICENSE AGREEMENT Between GEDEON RICHTER PLC. and ABBVIE GLOBAL ENTERPRISES LTD. Dated as of March 10, 2022 |
Confidential Confidential |
TABLE OF CONTENTS |
ARTICLE 1 DEFINITIONS ........................................................................................................... 1 |
ARTICLE 2 COLLABORATION MANAGEMENT .................................................................. 28 |
2.1 Joint Steering Committee ............................................................................................... 28 |
2.2 General Provisions of the JSC ....................................................................................... 30 |
2.3 Discontinuation of Participation on a Committee .......................................................... 33 |
2.4 Interactions Between a Joint Committee and Internal Teams ....................................... 33 |
2.5 Working Groups............................................................................................................. 33 |
2.6 Expenses ........................................................................................................................ 33 |
ARTICLE 3 DEVELOPMENT AND REGULATORY .............................................................. 33 |
3.1 Discovery Programs ....................................................................................................... 33 |
3.2 IND-Enabling Studies .................................................................................................... 35 |
3.3 Clinical Development Activities .................................................................................... 36 |
3.4 Required Richter Territory Development Activities...................................................... 38 |
3.5 Development and Regulatory Diligence ........................................................................ 39 |
3.6 Pre-Clinical and Clinical Supply of Licensed Compounds or Licensed Products; Subcontracting ............................................................................................................... 39 |
3.7 Subcontracting ............................................................................................................... 41 |
3.8 Supply of Technology for Development Purposes ........................................................ 41 |
3.9 Development Costs ........................................................................................................ 42 |
3.10 Regulatory Matters......................................................................................................... 46 |
ARTICLE 4 COMMERCIALIZATION ...................................................................................... 49 |
4.1 In General....................................................................................................................... 49 |
4.2 Diligence ........................................................................................................................ 50 |
4.3 Booking of Sales; Distribution ...................................................................................... 50 |
4.4 Coordination of Commercialization Activities .............................................................. 50 |
4.5 Pricing; Reimbursement Approvals ............................................................................... 50 |
4.6 Diversion ........................................................................................................................ 51 |
4.7 Product Trademarks ....................................................................................................... 51 |
End of preview. Expand
in Data Studio
No dataset card yet
- Downloads last month
- 11