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The Critical Material Attributes will be defined on the Collage™ (3mg/ml sterile solution) and will be applicable for the lyophilized rhCollagen low bioburden material. The following table describes only the release specifications related to the lyophilized rhCollagen low bioburden material. |
Attribute Category Rational Method Acceptance criteria |
Identity (type I)(1) physico-chemical release spec western blot Type I collagen |
Collagen Content release spec Sircol or Lowry X mg/dry weight (TBD) |
Moisture content release spec dry weight or oven Karl Fisher 5-10% |
Collagen purity (type I) (1) release spec collagenase assay > 95 % Type I Collagen |
appearance release spec visual White cake |
Rate of Fibrillogenesis biofunctional release spec fibrillogenesis assay >70% |
Endotoxins microbiological release spec LAL < 0.25 EU/mg |
heavy metals(1) Process-related impurities (first production phase) release spec ICP-MS or USP<231> < 5 ppm |
Total Aerobic Microbial Counts non -viral adventitious agents release spec USP <61> < 10 CFU/mg |
Total Yeast and Mold release spec USP <61> < 10 CFU/mg |
(1)Per results of the rhCollagen source (SPEC 0301) |
• If necessary, the attribute section will be subject to changes upon AbbVie approval. Once completed, some of the tests can be added to the release criteria upon AbbVie request. |
• Bioburden of the lyophilized material must be demonstrated and controlled. |
• Stability (physicochemical and microbiological) of the sterile material must be demonstrated based on ICH guidelines on stability (Q1A) for storage of raw material. Selection of the batches, packaging selection, specifications and testing frequency will be based on the ICH guidelines on stability and the stability pr... |
• For development purpose, 12 months stability results on the validation batches of the Lyophilized material. |
• Reconstituted solution from lyophilized material must have similar properties as the 20mg/ml, sterile rhCollagen solution (same acceptance criteria). |
Shelf life and stability test results should support packaging and storage for commercial purposes for the requirements below: |
• Packaging: Lyoguard tray • The parties will agree in the Definitive Agreements on the package specification. • Storage: Product should be stored at room temperature Shelf life: Product should be stable for at least 2 years under the designated storage conditions. |
A selection between 50mg/ml or lyophilized rhCollagen as the next phase following 20mg/ml Sterile rhCollagen Solution will be taken by AbbVie based on completion of a feasibility study. |
Feasibility study of the sterile, concentrated rhCollagen, 50 mg/ml: The feasibility phase refers to: • Completion of Work Package II described in Exhibit C |
Feasibility study of low bioburden, lyophilized rhCollagen: The feasibility phase refers to: • Completion of Work Package I described in Exhibit D • Tests results of the reconstituted solution from lyophilized material (compared to the 20mg/ml, sterile rhCollagen solution (same acceptance criteria except for sterility) |
Both feasibility studies can be run in parallel for a maximum period of time of 12 months. Selection of the option will be made by AbbVie 6 months after that period to include testing in final formulation. |
Schedule 1.26 CollPlant Patents |
Patent Name Application Number Priority Date Patent Status |
Collagen Producing Plants and Methods of Generating and Using Same WO2006/035442 09/2004 Granted: US, Europe, Mexico, Canada, Japan, Israel, Australia, Singapore, South Africa, New Zealand, India, Hong Kong, China, National Phase: Brazil |
Tobacco Transgenic Event and Methods for Detection and Use Thereof WO2020/026241 07/2018 PCT |
Methods of Processing Recombinant Procollagen WO2009/053985 10/2007 Granted: USA, Europe, Israel |
Compositions comprising collagen and PRP for tissue regeneration WO2014/147622 03/2013 Granted: USA, Israel National Phase: Europe, Canada, India |
Soft Tissue Filler and Implants US 62/992,998 03/2020 Prov. Application |
Dermal fillers and applications thereof WO2019/211854A1 05/2018 Prov. Application |
Schedule 2.5 Supply Agreement Term Sheet |
This term sheet outlines certain terms that would be included in a definitive supply agreement with CollPlant (the "Supply Agreement") to be entered into pursuant to the Agreement. Capitalized terms used but not defined in this term sheet will have the meaning attributed to them in the Agreement. |
1. Purpose and Scope of Supply Agreement Pursuant to the Supply Agreement, CollPlant will Manufacture and supply to AbbVie, and AbbVie will purchase from CollPlant, CollPlant Collagen to be used solely in the Development and Manufacture of Exclusive Products and Option Products (if and to the extent that AbbVie enters ... |
2. Product Information Until the First Stability Study is concluded under the Agreement, AbbVie may purchase at its discretion CollPlant Collagen at a concentration of 3mg/ml. |
After the First Stability Study is concluded under the Agreement and until such time as the Upscaled Facility (as defined below) is operational, all CollPlant Collagen supplied to AbbVie under the Supply Agreement will have the same concentration as the CollPlant Collagen that is the subject of the First Stability Stud... |
After the First Stability Study is concluded under the Agreement and after the Upscaled Facility is operational, all CollPlant Collagen supplied to AbbVie under the Supply Agreement will have the same or greater concentration as the CollPlant Collagen that is the subject of the First Stability Study. |
3. Supply Quantities and Price Until such time as the Upscaled Facility is operational, CollPlant will Manufacture and supply to AbbVie, at AbbVie's request, up to 2 kilograms of CollPlant Collagen per year at a price per gram of $1,800 (the "Initial Price"). |
After the Upscaled Facility is operational, CollPlant will Manufacture and supply to AbbVie, at AbbVie's request, up to 6 kilograms of CollPlant Collagen per year at a price per gram equal to the actual and documented cost of goods sold plus 7%; provided that the price per gram of such CollPlant Collagen (i.e., cost of... |
4. Manufacturing Facilities Unless otherwise mutually agreed by the Parties, CollPlant will only Manufacture CollPlant Collagen at the Initial Facilities or the Upscaled Facility. |
"Initial Facilities" means CollPlant's existing facilities in Rehovot and in Yessod Ha'maala, Israel. |
Upon AbbVie's written request at any time following payment of the First Application Milestone, CollPlant will, at CollPlant's sole cost and expense, either (i) initiate the design and construction of an expansion to its existing facilities in Rehovot and in Yessod Ha'maala, Israel and/or (ii) establish a new facility ... |
5. Manufacture by AbbVie or Third Parties If at any time during the term of the Supply Agreement, AbbVie desires to manufacture CollPlant Collagen at its own facility or have a Third Party manufacture CollPlant Collagen, then the Parties will enter into good faith negotiations to enter into a definitive agreement to pe... |
In addition, to ensure continuity of supply of CollPlant Collagen and to establish second sourcing capabilities (i) CollPlant will not prohibit any of its licensees, distributors or other partners from selling CollPlant Collagen to AbbVie and AbbVie from purchasing CollPlant Collagen from any of CollPlant's licensees, ... |
6. Additional Terms The Supply Agreement will contain supply terms related to ensuring that AbbVie is able to secure adequate and reliable supply of CollPlant Collagen as well as other customary terms for a supply agreement, including terms relating to: quality, audit and regulatory compliance, CollPlant subcontractors... |
The Supply Agreement will also include additional terms and conditions relating to commercial supply that are customary in transactions between strategic collaboration partners, including terms relating to confidentiality and the execution of a separate quality agreement governing quality assurance. |
The Supply Agreement will set forth key performance indicators, including the following: (i) continuous, uninterrupted supply, (ii) on time delivery, (iii) maintenance of safety stock requirements, (iv) ability to meet supply requirements in excess of forecasts, (v) avoidance of quality failures and (vi) root cause ana... |
The Supply Agreement will include processes for (x) the Parties to measure, report and review CollPlant's performance against the key performance indicators on an annual basis and (y) corrective actions and/or remedial measures to be taken. |
7. Indemnification CollPlant will defend, indemnify and hold harmless AbbVie against any claim arising from (a) CollPlant's or its Affiliates' breach of any representations, warranties, or covenants under the Supply Agreement, (b) CollPlant's or its Affiliates' failure to comply with applicable Law in the performance o... |
8. Term Subject to Section 9 below, the Supply Agreement will remain in effect until the termination or expiration of the Royalty Term under the Agreement with an ability on the part of AbbVie to extend the Supply Agreement for up to an additional 18 months so long as AbbVie shall agree to continue to pay royalties to ... |
9. Termination, Effects of Termination As long as the Agreement is in effect, and AbbVie has not breached its applicable obligations under the Supply Agreement (subject to all applicable cure periods), CollPlant will have no right to terminate the Supply Agreement. |
Either Party may terminate the Supply Agreement for the other Party's material breach following a 90-day cure period, which may be tolled in the event of a dispute. |
Schedule 9.2 CollPlant Disclosure Schedule |
Schedule 9.2.10 Disputes |
Fibrogen Opposition Proceedings to first generation European Patents Nos. 1 809 751 B1, 2 357 241 B1 (divisional) and 2 816 117 B1 (divisional). 1st generation European Patent and two divisional patents were granted by the European Patent Office (EPO) in 2010, 2015 and 2016, respectively. In 2011, Fibrogen, Inc. filed ... |
Schedule 9.2.16 Use of Academic Facilities and Personnel |
Prof. Oded Shoseyov Prof. Oded Shoseyov, CollPlant's chief scientist, co-founded CollPlant Ltd. in 2004. Throughout the period commencing 2004 and to this day, Prof. Shoseyov has been a faculty member of the Hebrew University of Jerusalem and during the years 2004-2007, he conducted his research and development work co... |
Prof. Shoseyov is engaged with CollPlant by a consulting agreement. Under the provisions of the consulting agreement, CollPlant has complete ownership in any invention which is derived from CollPlant's operations and businesses. |
Agreement with Yissum Research Development Company of the Hebrew University of Jerusalem Ltd. with respect to CollPlant Collagen Under an agreement dated July 13, 2004 among Meytav Technological Enterprises Initiation Center Ltd., Yehuda Zafrir Feigin, Yissum - the Company for the Development of Research of the Hebrew ... |
Both Yissum and Professor Shoseyov have assigned all intellectual property rights developed by Professor Shoseyov and owned by them to CollPlant, including the intellectual property rights in connection with the development of the method for production of quality human collagen in plants. |
Schedule 12.2.2 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... |
Except as expressly set forth in subparagraphs 4(a) - 4(d), no discovery shall be required or permitted by any means, including depositions, interrogatories, requests for admissions, or production of documents. |
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... |
7. The Neutral shall rule on each disputed issue within fourteen (14) days following completion of the hearing. Such ruling shall adopt in its entirety the proposed ruling and remedy of one (1) of the Parties on each disputed issue but may adopt one (1) Party's proposed rulings and remedies on some issues and the other... |
8. The Neutral shall be paid a reasonable fee plus expenses. These fees and expenses, along with the reasonable legal fees and expenses of the prevailing Party (including all expert witness fees and expenses), the fees and expenses of a court reporter, and any expenses for a hearing room, shall be paid as follows: (a) ... |
9. The rulings of the Neutral and the allocation of fees and expenses shall be binding, non-reviewable, and non-appealable, and may be entered as a final judgment in any court having jurisdiction. |
10. Except as provided in paragraph 9 or as required by Law, the existence of the Dispute, any settlement negotiations, the ADR proceeding, any submissions (including exhibits, testimony, proposed rulings, and briefs), and the rulings shall be deemed to be Confidential Information of both Parties. The Neutral shall hav... |
11. All ADR proceedings shall be conducted in the English language. |
12. Each Party shall have the right to be represented by counsel in all aspects of any ADR proceeding. |
Execution Version |
OPTION AND LICENSE AGREEMENT between ALPINE IMMUNE SCIENCES INC. and ABBVIE IRELAND UNLIMITED COMPANY Dated as of June 17, 2020 |
TABLE OF CONTENTS |
ARTICLE 1 DEFINITIONS .............................................................................................................................. 1 |
ARTICLE 2 LICENSOR ACTIVITIES ........................................................................................................... 22 2.1 Pre-Option Development ........................................................................................................ 22 2.2 Regulatory Matters ........................ |
ARTICLE 3 GOVERNANCE .......................................................................................................................... 27 3.1 Joint Governance Committee ................................................................................................. 27 |
ARTICLE 4 OPTION AND OPTION EXERCISE ......................................................................................... 31 4.1 AbbVie Option ....................................................................................................................... 31 4.2 Option Exercise ................................ |
ARTICLE 5 POST-OPTION ACTIVITIES ..................................................................................................... 35 5.1 Technology Transfer .............................................................................................................. 35 5.2 Development ............................... |
ARTICLE 6 PAYMENTS AND RECORDS ................................................................................................... 41 6.1 Upfront Payment .................................................................................................................... 41 6.2 Development Milestones by Licensor .......... |
6.11 Interest on Late Payments ...................................................................................................... 46 6.12 Audit ....................................................................................................................................... 46 6.13 Audit Dispute ................. |
ARTICLE 7 INTELLECTUAL PROPERTY RIGHTS ................................................................................... 47 7.1 Ownership of Intellectual Property Rights ............................................................................. 47 7.2 Prosecution of Patents ........................................... |
ARTICLE 8 DATA PRIVACY AND SECURITY .......................................................................................... 58 8.1 Data Privacy and Security ...................................................................................................... 58 8.2 Data Agreements ..................................... |
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE .................................................................... 59 9.1 Product Information................................................................................................................ 59 9.2 Confidentiality Obligations ................................... |
ARTICLE 10 REPRESENTATIONS AND WARRANTIES.......................................................................... 64 10.1 Mutual Representations and Warranties ................................................................................. 64 10.2 Additional Representations, Warranties and Covenants of Licensor ...... |
ARTICLE 11 INDEMNITY ............................................................................................................................. 69 11.1 Indemnification of Licensor ................................................................................................... 69 11.2 Indemnification of AbbVie. ..... |
ARTICLE 12 TERM AND TERMINATION .................................................................................................. 73 12.1 Term ....................................................................................................................................... 73 12.2 Termination for Material Breach ... |
ARTICLE 13 MISCELLANEOUS .................................................................................................................. 79 13.1 Subcontracting ........................................................................................................................ 79 13.2 Force Majeure ................. |
SCHEDULES Schedule 1.14: ALPN-101 Schedule 1.97-A: Other Licensed Molecules Schedule 1.97-B: Cellular Binding Assay Protocol Schedule 1.97-C: ALPN-202 Schedule 1.120: Option Exercise Data Package Schedule 1.121: Option Exercise Data Package Trigger Event Schedule 1.157: Bridging Study Success Completion Criteria Schedu... |
OPTION AND LICENSE AGREEMENT |
This Option and License Agreement (the "Agreement") is made and entered into effective as of June 17, 2020 (the "Effective Date") by and between Alpine Immune Sciences Inc., a Delaware corporation having its principal place of business at 188 East Blaine St, Suite 200, Seattle, WA 98102, United States ("Licensor"), and... |
RECITALS |
WHEREAS, Licensor Controls (as defined herein) certain intellectual property rights with respect to the Licensed Compound (as defined herein) and Licensed Products (as defined herein) in the Territory (as defined herein); and |
WHEREAS, Licensor wishes to grant, and AbbVie wishes to take, an exclusive option to take an exclusive license under such intellectual property rights to research, develop, manufacture, commercialize and otherwise exploit Licensed Compounds and Licensed Products in the Field in the Territory, in each case in accordance... |
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows: |
ARTICLE 1 DEFINITIONS |
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