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11.3.5 Notwithstanding Sections 11.3.1 and 11.3.2, in the event that Section 11.3 is invoked by AbbVie as a result of a material breach on the part of CollPlant, if CollPlant subsequently cures such breach the reductions set forth in Sections 11.3.1 and 11.3.2 shall prospectively be eliminated following such cure such ... |
11.4 Effects of Termination of Agreement. |
11.4.1 Without limiting any other legal or equitable remedies that either Party may have under this Agreement, in the event of any termination of this Agreement, all rights granted by either Party to the other Party under this Agreement will immediately terminate with respect to the Terminated Products and Terminated T... |
11.5 Effects of Termination in Terminated Territory. Without limiting any other legal or equitable remedies that either Party may have under this Agreement, in the event of a termination of this Agreement with respect to a country by AbbVie pursuant to Section 11.2.2 (Termination by AbbVie) (but not in the case of any ... |
11.6 Accrued Rights; Surviving Provisions of the Agreement. |
11.6.1 Accrued Rights. Termination or expiration of this Agreement either in its entirety or with respect to one (1) or more Exclusive Products for any reason shall be without prejudice to any rights that shall have accrued to the benefit of either Party prior to such termination or expiration, including the payment ob... |
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11.6.2 Surviving Provisions of the Agreement. Without limiting Section 11.6.1 (Accrued Rights), the following Sections and Articles shall survive the termination of this Agreement in its entirety or expiration of this Agreement for any reason, in accordance with their respective terms and conditions, and for the durati... |
11.6.3 Notwithstanding the termination of AbbVie's rights under this Agreement, AbbVie and its Affiliates and Third Party Transferees shall have the right for twelve (12) months after the effective date of such termination to sell or otherwise dispose of all Terminated Products then in its or their respective inventory... |
ARTICLE 12 - MISCELLANEOUS |
12.1 Governing Law; Service. |
12.1.1 Governing Law. This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed and enforced in accordance with the Laws of the State of New York without reference to conflicts of laws principles; provided that, subject to the requirements of the IIA, all questions ... |
12.1.2 Service. Each Party further agrees that service of any process, summons, notice or document by certified mail to its address set forth in Section 12.5 (Notices) shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any such court. |
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12.2 Dispute Resolution. Except for disputes resolved by the procedures set forth in Section 6.10.2 (Audit Dispute) or Section 12.11 (Equitable Relief), if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith, including the ... |
12.2.1 General. Any Dispute shall first be referred to the Executive Officers of the Parties, who shall confer on the resolution of the issue. Any final decision mutually agreed to by the Executive Officers shall be conclusive and binding on the Parties. If the Executive Officers are not able to agree on the resolution... |
12.2.2 ADR. Subject to Section 12.2.1 (General) and Section 12.2.3 (Intellectual Property Disputes), any ADR proceeding under this Agreement shall take place pursuant to the procedures set forth in Schedule 12.2.2 (ADR). |
12.2.3 Intellectual Property Disputes. Unless otherwise agreed by the Parties in writing, a Dispute between the Parties relating to the validity, enforceability or patentability of any Patent Right, Trademark or other intellectual property rights, if not resolved in accordance with Section 12.2.1 (General), shall not b... |
12.2.4 Adverse Ruling. Any determination pursuant to this Section 12.2 (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. |
12.2.5 Interim Relief. Notwithstanding anything herein to the contrary, nothing in this Section 12.2 (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 Dispute, if nec... |
12.3 Assignment. |
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12.3.1 This Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred (except as provided in Sections 5.4 (Subcontracting)), whether by operation of law or otherwise, in whole or in part, by either Party without the written consent of the other Party, w... |
12.3.2 AbbVie agrees that, notwithstanding any provision of this Agreement to the contrary, if CollPlant undergoes a Change of Control, AbbVie will not have any rights under this Agreement to any Patent Right, Know-How or other intellectual property or other proprietary rights directed to the Exclusive Product and/or C... |
12.4 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... |
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12.5 Notices. 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 transmission confirmed... |
If to CollPlant, addressed to: CollPlant Ltd. Oppenheimer 4 Rehovot, Israel 7670104 |
with a copy to: Marina Gofman Feler, Legal Counsel |
If to AbbVie, addressed to: Allergan Industrie S.A.S. Route de Promery, Zone Artisanale de Pre-Mairy, 74370 Pringy, France |
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with a copy (which shall not constitute notice) to: AbbVie Inc. 1 North Waukegan Road North Chicago, Illinois 60064 United States Attention: Vice Chairman, External Affairs, Chief Legal Officer and Corporate Secretary |
If to APIL, addressed to: Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock Dublin 17 Ireland |
with a copy (which shall not constitute notice) to: AbbVie Inc. 1 North Waukegan Road North Chicago, Illinois 60064 United States Attention: Vice Chairman, External Affairs, Chief Legal Officer and Corporate Secretary |
12.6 Export Clause. 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 will not export, directly or indirectly, any technical information a... |
12.7 Waiver; 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. The wa... |
12.8 No Benefit to Third Parties. The 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. |
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12.9 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... |
12.10 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 will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agre... |
12.11 Equitable Relief. CollPlant acknowledges and agrees that the restrictions, rights and obligations set forth in Article 2 - (Development; Right of First Negotiation) and Section 4.1 (Grant of Exclusive Rights to AbbVie) through Section 4.4 (Covenant Not to Sue), and each Party acknowledges and agrees that the rest... |
12.12 Entire Agreement; Amendments. This Agreement, together with the Schedules and Exhibits attached hereto and the Supply Agreement (once executed by the Parties), sets forth and constitutes the entire agreement and understanding between the Parties with respect to the subject matter hereof and all prior agreements, ... |
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12.13 Relationship of the Parties. It is expressly agreed that CollPlant, 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 CollPlant, on the... |
12.14 Headings; Construction; Interpretation. Headings and any table of contents used herein are for convenience only and shall not in any way affect the construction of or be taken into consideration in interpreting this Agreement. The language of this Agreement shall be deemed to be the language mutually chosen by th... |
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12.15 Books and Records. Any books and records to be maintained under this Agreement by a Party or its Affiliates or Third Party Transferees shall be maintained in accordance with applicable Accounting Standards. |
12.16 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... |
12.17 Parties in Interest. Except as provided in Article 10 - (Indemnification; Insurance), all of the terms and provisions of this Agreement shall be binding upon, and shall inure to the benefit of and be enforceable solely by the Parties and their respective successors, heirs, administrators and permitted assigns and... |
12.18 Counterparts. This Agreement may be signed in counterparts, each and every one of which shall be deemed an original, notwithstanding variations in format or file designation which may result from the electronic transmission, storage and printing of copies from separate computers or printers. Facsimile signatures ... |
[Signature page to follow] |
[Signature Page to Development, Exclusivity and Option Products Agreement] |
IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date. |
CollPlant Ltd. By: Name: Title: |
Allergan Industrie S.A.S. By: Name: Title: |
Solely for the purpose of Section 2.3 (Right of First Negotiation for Option Products), Section 6.1 (Upfront Fee), Section 6.2 (Option Exercise Fee), Section 7.3.4 (Option Products) and the terms of Section 6.4 (Milestone Payments) through Section 6.7 (Royalty Adjustments) that specifically apply to APIL: Allergan Phar... |
Yehiel Tal Eran Rotem CEO Deputy CEO&CFO |
Exhibit A CollPlant Collagen |
The following preliminary specifications refer to: |
1. Collage™ - 3mg/ml rhCollagen Solution, sterile material |
Product Description 3mg/ml rhCollagen is a solution at a nominal concentration of 3mg/ml recombinant human collagen type I in 10mM hydrochloric acid. The rhCollagen solution will be aseptically processed. |
Minimum Batch Size: 50g |
Minimize Sample Size for AbbVie Confirmatory Testing: 3 batches of minimum batch size |
Proposed release criteria based on current specifications of Collage™ (3mg/ml, sterile rhCollagen solution) |
Attribute Category Rational Method Acceptance criteria |
pH physico-chemical release spec pH meter 2.0 – 2.4 |
Identity (type I) release spec western blot Type I Collagen |
Collagen Concentration release spec Sircol 2.5-3.5 mg/ml |
Collagen purity (type I) release spec collagenase assay > 95 % Type I Collagen |
appearance (no visible particulate) release spec visual Clear, colorless liquid |
Rate of Fibrillogenesis biofunctional release spec fibrillogenesis assay >70% |
Sterility microbiological release spec USP <71> No growth |
Endotoxins release spec LAL < 0.25 EU/mg |
heavy metals Process-related impurities (first production phase) release spec ICP-MS or USP<231> < 5 ppm |
The above specifications will be tested by AbbVie to characterize the Collage™ that will be used to develop the rhCollagen products described in Exhibit E. |
Critical Material Attributes for Collage™ (3mg/ml, Sterile rhCollagen Solution (pending development phase)): |
The following Collage™ attributes have to be evaluated and, based on risk assessment, the Critical Material Attributes will be defined by CollPlant and AbbVie. 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... |
Attribute Category Rational Method Acceptance criteria |
Structural integrity of collagen trimer physico-chemical impact on function CD; fibrillation of collagen [TBD] |
pro hydroxylation potential impact on trimer formation; in solution hydrolysis aaa analysis; peptide map [TBD] |
lys hydroxylation aaa analysis; peptide map [TBD] |
pro hydroxyglycosylation aaa analysis; peptide map [TBD] |
lys hydroxyglycosylation aaa analysis; peptide map [TBD] |
COL-1/COL-2 ratio LC-UV; peptide map [TBD] |
truncation products Product-related impurities immunogenicity LC-MS [TBD] |
higher order species immunogenicity; impact on cross-linking SEC-UV/MALLS [TBD] |
HCP Process-related impurities (host plant) immunogenicity LC-MS/ ELISA [TBD] |
Proteases immunogenicity; product relates impurities LC-MS/ ELISA [TBD] |
plant DNA immunogenicity PCR [TBD] |
total monosaccharides GC-MS [TBD] |
secondary metabolites safety LC-MS [TBD] |
fertilisers* Process-related impurities (first production phase) safety [TBD] [TBD] |
pesticides* safety [TBD] [TBD] |
Solvents* safety [TBD] [TBD] |
DSP materials** safety [TBD] [TBD] |
hantaviruses*** viral adventitious agents safety [TBD] [TBD] |
minute virus of mice*** safety [TBD] [TBD] |
avian influenza virus*** safety [TBD] [TBD] |
hepatitis A virus*** safety [TBD] [TBD] |
*can be risk assessed based on plant growth control **can be risk assessed based on process understanding ***can be risk assessed based on controls in place to avoid crop contamination by pests |
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