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13.6.2 Service. Each Party further agrees that service of any process, summons, notice or document by registered mail to its address set forth in Section 13.8.2 (Address for Notice) shall be effective service of process for any action, suit or proceeding brought against it under this Agreement in any court. |
13.7 Dispute Resolution. Except for disputes resolved by the procedures set forth in Section 3.1.5 (Dispute Resolution), 6.13 (Audit Dispute) or 13.11 (Equitable Relief), any dispute arising out of, relating to, or in connection with this Agreement, including any question regarding its existence, validity or terminatio... |
13.7.1 General. Any Dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of such Dispute. Any final decision mutually agreed to by the Senior Officers shall be conclusive and binding on the Parties. If the Senior Officers are not able to agree on the re... |
13.7.2 Intellectual Property Right Disputes. In the event that a Dispute arises with respect the validity, patentability, scope, enforceability, inventorship or ownership of any Patent, Trademark or other intellectual property right, and such Dispute cannot be resolved in accordance with Section 13.7.1 (General), unles... |
13.7.3 Adverse Ruling. Any determination pursuant to this Section 13.7 (Dispute Resolution) that a Party is in material breach of its material obligations hereunder shall specify a (nonexclusive) set of actions to be taken to cure such material breach, if feasible. |
13.7.4 Interim Relief and Tolling. Notwithstanding anything herein to the contrary, nothing in this Section 13.7 (Dispute Resolution) shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction or other interim equitable relief concerning a Dis... |
13.8 Notices. |
13.8.1 Notice Requirements. Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if (a) delivered by hand, (b) sent by facsimile transmission (with transmiss... |
13.8.2 Address for Notice. If to AbbVie, to: AbbVie Ireland Unlimited Company c/o PricewaterhouseCoopers Financial Services Limited 4th Floor, Washington House 16 Church Street Hamilton HM11, Bermuda Attention: Vice President, Tax & Treasury with a copy (which shall not constitute notice) to: AbbVie Inc. 1 North Waukeg... |
13.9 Entire Agreement; Amendments. This Agreement, together with the Schedules attached hereto, sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, understandings, promises and representations, whether written or oral,... |
13.10 English Language. This Agreement shall be written and executed in, and all other communications under or in connection with this Agreement shall be in, the English language. Any translation into any other language shall not be an official version thereof, and in the event of any conflict in interpretation between... |
13.11 Equitable Relief. Each Party acknowledges and agrees that the restrictions set forth in Section 2.4 (Exclusivity) and ARTICLE 7 (Intellectual Property Rights) and ARTICLE 9 (Confidentiality and Non-Disclosure) are reasonable and necessary to protect the legitimate interests of the other Party and that such other ... |
13.12 Waiver and Non-Exclusion of Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. Th... |
13.13 No Benefit to Third Parties. Except as provided in ARTICLE 11 (Indemnity), covenants and agreements set forth in this Agreement are for the sole benefit of the Parties hereto and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other Persons. |
13.14 Further Assurance. Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary or as the other Party ma... |
13.15 Relationship of the Parties. It is expressly agreed that Licensor, on the one hand, and AbbVie, on the other hand, shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture or agency, including for all tax purposes. Neither Licensor, on the on... |
13.16 Counterparts; Facsimile Execution. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument. This Agreement may be executed by facsimile or electronically transmitted signatures and such si... |
13.17 References. Unless otherwise specified, (a) references in this Agreement to any Article, Section or Schedule shall mean references to such Article, Section or Schedule of this Agreement, (b) references in any Section to any clause are references to such clause of such Section, and (c) references to any agreement,... |
13.18 Schedules. In the event of any inconsistencies between this Agreement and any schedules or other attachments hereto, the terms of this Agreement shall control. |
13.19 Construction. Except where the context otherwise requires, wherever used, the singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all genders and the word "or" is used in the inclusive sense (and/or). Whenever this Agreement refers to a number of days, unless o... |
THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the Effective Date. |
ALPINE IMMUNE SCIENCES INC. ABBVIE IRELAND UNLIMITED COMPANY |
By: By: |
Name: Name: Scott Reents |
Title: Title: Director |
Paul Rickey |
CFO |
Schedule 1.14 ALPN-101 |
ALPN-101 is a homodimeric Fc1.1-fusion protein consisting of 2 identical ICOSL Fc1.1-fusion protein chains covalently linked through the Fc Hinge region disulfide bonds. Each chain contains a variant ICOSL IgV domain fused amino-terminally to the variant human IgG1 Fc designated as Fc1.1. |
The amino acid sequence of ALPN-101 is set forth below: |
DTQEKEVRAM VGSDVELSCA CPEGSRFDLN DVYVYWQTSE SKTVVTYHIP QHSSLEYVDS RYRNRALMSP AGMLRGDFSL RLFNVTPQDE QKFHCLVLSR SLGFQEVLSV EVTLHVAANF SVGGGGSGGG GSEPKSSDKT HTCPPCPAPE AEGAPSVFLF PPKPKDTLMI SRTPEVTCVV VDVSHEDPEV KFNWYVDGVE VHNAKTKPRE EQYNSTYRVV SVLTVLHQDW LNGKEYKCKV SNKALPAPIE KTISKAKGQP REPQVYTLPP SRDELTKNQV SLTCLVKGFY P... |
Schedule 1.97-A Other Licensed Molecules |
None known or identified as of the Effective Date |
Schedule 1.97-B Cellular Binding Assay Protocol |
Attached below. |
Pharmacology Study Report Alpine Immune Sciences, Inc. ALPN100-PHRM-001 |
1 |
TIE PAGE |
ALPN-101: TARGET BINDING AND AFFINITY ALPN100-PHRM-001 PHARMACOLOGY REPORT |
Author: Lawrence S. Evans, BSc 201 Elliott Ave. West, Suite 230 Seattle WA, 98119 |
Release date of report: September 21, 2018 |
Study Director: Lawrence S. Evans, BSc |
Primary test facility: Alpine Immune Sciences, Inc. 201 Elliott Ave. West, Suite 230 Seattle WA, 98119 |
Experimental work started: December 4, 2017 |
Experimental work completed: June 13, 2018 |
Referenced studies: ALPN100-CMC-001 ALPN100-CMC-002 ALPN100-CMC-003 |
Pharmacology Study Report Alpine Immune Sciences, Inc. ALPN100-PHRM-001 |
3 |
1. TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES |
TABLE OF CONTENTS TITLE PAGE ...................................................................................................................................1 |
REVIEWER SIGNATURES ...........................................................................................................2 |
1. TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES .................3 |
2. LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS...............................6 |
3. ABSTRACT .................................................................................................................7 |
4. STUDY RATIONALE AND OBJECTIVES ...............................................................8 |
5. STUDY MATERIALS .................................................................................................9 |
5.1. Test Articles ..................................................................................................................9 |
5.2. Test Materials ...............................................................................................................9 |
5.3. Analysis Tools ............................................................................................................10 |
5.4. Test System .................................................................................................................11 |
6. EXPERIMENTAL PROCEDURES ...........................................................................12 |
6.1. Flow Cytometric Analysis: .........................................................................................12 |
6.1.1. Cell Transfections (Day 0) ..........................................................................................12 |
6.1.2. FACS Staining (Day 2) ...............................................................................................12 |
6.2. Bio-Layer Interferometry (BLI) Analysis: .................................................................12 |
7. DATA ANALYSIS ....................................................................................................14 |
8. STORAGE OF DATA ................................................................................................21 |
9. RESULTS ...................................................................................................................22 |
10. CONCLUSIONS ........................................................................................................23 |
11. REFERENCES ...........................................................................................................24 |
12. APPENDICES ............................................................................................................25 |
Pharmacology Study Report Alpine Immune Sciences, Inc. ALPN100-PHRM-001 |
4 |
LIST OF TABLES Table 1: Abbreviations and Specialist Terms .............................................................................6 |
Table 2: Test Articles Used in Study ALPN100-PHRM-001 .....................................................9 |
Table 3: Test Materials Used in Study ALPN100-PHRM-001 ..................................................9 |
Table 4: Analysis Tools Used in Study ALPN100-PHRM-001 ...............................................11 |
Table 5: ALPN-101 Binding Affinity (EC50) to CD28, ICOS, and CTLA-4 Across Species Assessed by Flow Cytometric Analysis ........................................................16 |
Table 6: ALPN-101 Demonstrates Superior Binding to CD28 Compared to that of WT ICOSL-Fc1.1 .......................................................................................................17 |
Table 7: ALPN-101 KD, ka, kd, Errors, and Full R2 Measured by BLI Analysis.....................18 |
Table 8: ALPN-101 Flow Cytometric Raw Binding Values (MFI): Human Counter Structures ....................................................................................................................25 |
Table 9: ALPN-101 Flow Cytometric Raw Binding Values (MFI): Cynomolgus Counter Structures ....................................................................................................................26 |
Table 10: ALPN-101 Flow Cytometric Raw Binding Values (MFI): Rat Counter Structures ....................................................................................................................27 |
Table 11: ALPN-101 Flow Cytometric Raw Binding Values (MFI): Mouse Counter Structures ....................................................................................................................28 |
Table 12: ALPN-101 Flow Cytometric Raw Binding Values (MFI): Mock Transfectants ...............................................................................................................29 |
Table 13: ALPN-101 BLI Binding Responses for Each Replicate in the Titrations ..................30 |
Pharmacology Study Report Alpine Immune Sciences, Inc. ALPN100-PHRM-001 |
5 |
LIST OF FIGURES Figure 1: Flow Cytometric Analysis Gating Strategy (A) and Representative Histograms of ALPN-101 Binding to Human Counter Structures (B) .......................14 |
Figure 2: ALPN-101 Binding to Human, Cynomolgus Monkey, Rat, and Mouse CD28, ICOS, and CTLA-4 .........................................................................................15 |
Figure 3: General Description of Binding Sensorgrams ............................................................19 |
Figure 4: CD28 Binding Sensorgram .........................................................................................19 |
Figure 5: ICOS Binding Sensorgram .........................................................................................20 |
Figure 6: CTLA-4 Binding Sensorgram .....................................................................................20 |
Pharmacology Study Report Alpine Immune Sciences, Inc. ALPN100-PHRM-001 |
6 |
2. LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS |
Table 1: Abbreviations and Specialist Terms |
Abbreviation or specialist term Explanation |
AIS Alpine Immune Sciences, Inc. |
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