text stringlengths 1 5.46k |
|---|
12.7.1 If such termination right arises prior the completion of the activities under the then-current Development Plan, AbbVie shall have the right, in its sole and absolute discretion, by written notice delivered to Licensor, to conduct any activities allocated to Licensor under such Development Plan and all such acti... |
12.7.2 In the event that AbbVie delivers notice to Licensor of its exercise of the right to conduct activities allocated to Licensor under the Development Plan prior to the Option Effective Date, Licensor hereby grants, and shall cause its Affiliates to grant, to AbbVie an exclusive license (including with regard to Li... |
12.7.3 AbbVie shall have the right, at AbbVie's sole election, to disband the JGC and terminate the activities of the JGC and thereafter undertake all activities assigned by this Agreement to the JGC solely and exclusively by itself; |
12.7.4 if AbbVie has such right to terminate prior to the Option Effective Date, the Option shall remain in effect, but the Option Exercise Fee shall be reduced by an amount equal to fifty percent (50%) of the Option Exercise Fee; |
12.7.5 if (a) AbbVie has such right to terminate prior to the Option Effective Date, the amount of any milestone payment payable by AbbVie to Licensor under Section 6.2 (Development Milestone by Licensor), Section 6.3 (Development Milestone by AbbVie) or Section 6.5 (Sales-Based Milestones) for any milestone event achi... |
12.7.6 AbbVie's diligence obligations under Section 5.7 (AbbVie Diligence) shall terminate; and |
12.7.7 all other provisions of this Agreement shall remain in full force and effect without change. |
12.8 Termination in Entirety. |
12.8.1 In the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.3 (Termination Right by AbbVie For Convenience) or Section 12.6 (Termination for Failure or Delay to Obtain HSR Clearance), or Licensor pursuant to Section 12.2 (Material Breach) or 12.4 (Termination for Insolvency): |
(a) all rights and licenses, including the Option, if unexercised, granted by Licensor hereunder shall immediately terminate; |
(b) all rights and licenses granted by AbbVie hereunder shall immediately terminate; and |
(c) at Licensor's request, the Parties shall negotiate in good faith to agree upon the terms pursuant to which (i) AbbVie would grant to Licensor an exclusive or non-exclusive, royalty-bearing license (or sublicense) under AbbVie's interest in any AbbVie Grantback Patents and AbbVie Grantback Know-How solely to Exploit... |
12.8.2 In the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.2 (Material Breach) or 12.4 (Termination for Insolvency), all rights and licenses granted by either Party hereunder shall immediately terminate. |
12.9 Termination of Terminated Territory. In the event of a termination of this Agreement with respect to a country or other jurisdiction by AbbVie pursuant to Section 12.3 (Termination Right by AbbVie For Convenience) or with respect to a Terminated Territory by Licensor pursuant to Section 12.2.2 (Material Breach Rel... |
12.9.1 all rights and licenses granted by Licensor hereunder (a) shall automatically be deemed to be amended to exclude, if applicable and subject to Section 12.9.1(b) (Termination of Terminated Territory), the right to Develop, market, promote, detail, distribute, import, sell, offer for sale, file any Drug Approval A... |
12.9.2 at Licensor's request, the Parties shall negotiate in good faith to agree upon the terms pursuant to which AbbVie would grant to Licensor an exclusive or non-exclusive, royalty-bearing license (or sublicense) under AbbVie's interest in any AbbVie Grantback Patents and AbbVie Grantback Know-How in such country or... |
12.10 Remedies. Except as otherwise expressly provided herein, termination of this Agreement (either in its entirety or with respect to one (1) or more country(ies) or other jurisdiction(s)) in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. |
12.11 Accrued Rights; Surviving Obligations. |
12.11.1 Termination or expiration of this Agreement (either in its entirety or with respect to one (1) or more country(ies) or other jurisdiction(s)) for any reason shall be without prejudice to any rights that shall have accrued to the benefit of a Party prior to such termination or expiration. Such termination or exp... |
12.11.2 Notwithstanding the termination of AbbVie's licenses and other rights under this Agreement or with respect to a particular Major Market or country or other jurisdiction, as the case may be, to the extent a Licensed Product has obtained Regulatory Approval as of such time, AbbVie shall have the right for one (1)... |
ARTICLE 13 MISCELLANEOUS |
13.1 Subcontracting. Licensor shall have the right to subcontract any of its activities under this Agreement to an Affiliate of Licensor or a Third Party (a "Third Party Provider") with AbbVie's prior written consent; provided that Licensor shall have such right to subcontract to any of the approved Third Party Provide... |
13.2 Force Majeure. Neither Party shall be held liable or responsible to the other Party or be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of this Agreement when such failure or delay is caused by or results from events beyond the reasonable contro... |
13.3 Export Control. This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries that may be imposed on the Parties from time to time. Each Party agrees that it shall not export, directly or indirectly, any technical information... |
13.4 Assignment. Without the prior written consent of the other Party, such consent not to be unreasonably withheld, conditioned or delayed, neither Party shall sell, transfer, assign, delegate, pledge or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any o... |
13.5 Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any present or future law, and if the rights or obligations of either Party under this Agreement shall not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agree... |
13.6 Governing Law, Jurisdiction and Service. |
13.6.1 Governing Law. This Agreement or the performance, enforcement, breach or termination hereof shall be interpreted, governed by and construed in accordance with the laws of the State of Delaware, United States, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or in... |
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 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.