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12.6.2 In the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.3.1, Section 12.3.2, Section 12.3.3 or Section 12.3.4 or by OSE pursuant to Section 12.3.1 or Section 12.3.4: (a) all rights and licenses granted by OSE hereunder shall immediately terminate, (b) the receiving Party ... |
12.6.3 Without limiting any other remedies or termination rights hereunder, in the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.3.5 for breach of Section 10.2.20, all rights and licenses granted by OSE hereunder shall become irrevocable, unrestricted, and perpetual rights an... |
12.7 Termination of Terminated Territory. In the event of a termination of this Agreement with respect to a Terminated Territory by AbbVie pursuant to Section 12.3.3 or by OSE pursuant to Section 12.3.1 (but not in the case of any termination of this Agreement in its entirety): |
12.7.1 all rights and licenses granted by OSE hereunder (a) shall automatically be deemed to be amended to exclude, if applicable, the right to market, promote, detail, distribute, sell, offer for sale, file any Drug Approval Application for, or seek any Regulatory Approval for Licensed Antibodies and Licensed Products... |
12.7.2 AbbVie hereby grants to OSE an exclusive and irrevocable option to acquire an exclusive or non-exclusive (at AbbVie's sole election) license solely for Exploitation of the Licensed Antibody and Licensed Compound in the Terminated Territory, with the right to sublicense through multiple tiers, Patents and Know-Ho... |
12.8 Grantback Transition Agreement. |
12.8.1 In the event of any termination of this Agreement, whether in its entirety or with respect to the Terminated Territory, OSE and AbbVie shall negotiate in good faith the terms and conditions of a written transition agreement (the "Grantback Transition Agreement") pursuant to which AbbVie and OSE will effectuate a... |
(a) In the event of a termination of this Agreement in its entirety by AbbVie pursuant to Section 12.3.2 or Section 12.3.3 or by OSE pursuant to Section 12.3.1 or 12.3.4, the Grantback Transition Agreement shall provide that AbbVie shall (and shall cause its Affiliates to) where permitted by Applicable Law, transfer to... |
(b) In the event of a termination of this Agreement with respect to a country or other jurisdiction by AbbVie pursuant to Section 12.3.3 or by OSE pursuant to Section 12.3.1 (but not in the case of any termination of this Agreement in its entirety), the Transition Agreement shall: (x) include provisions regarding the m... |
12.9 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. |
12.10 Accrued Rights; Surviving Obligations. |
12.10.1 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; provided that in no event... |
12.10.2 Without limiting the foregoing, Section 6.1 through Section 6.13 (to the extent of accrued rights to payment that were not satisfied prior to expiration or termination), Section 6.15 (solely for a period not to exceed three (3) years after expiration or termination); Sections 7.1, and this Section 12.10.2, and ... |
12.10.3 Notwithstanding the termination of AbbVie's licenses and other rights under this Agreement, AbbVie shall have the right for one (1) year after the effective date of such termination with respect to the Terminated Territory to sell or otherwise dispose of all Licensed Antibodies and Licensed Products then in its... |
ARTICLE 13 MISCELLANEOUS |
13.1 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... |
13.2 Change in Control of OSE. |
13.2.1 OSE (or its successor) shall provide AbbVie with written notice of any Change in Control of OSE or Acquisition by OSE within two (2) Business Days following the closing date of such transaction. |
13.2.2 In the event that a Change in Control of OSE or Acquisition by OSE, results in OSE (or its successor) having rights or access any product that is an Antibody that binds to, inhibits or otherwise modulates ChemR23 and any fragments or altered, modified improved forms of such antibodies (a "Competing Product"), th... |
13.2.3 OSE covenants that, following a Change in Control of OSE, if the Change of Control occurs during the Transition Term, (a) there shall be no material change in the level or nature of efforts or resources expended by OSE and its Affiliates with respect to, or the qualifications and experience of the personnel assi... |
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 will not export, directly or indirectly, any technical information ... |
13.4 Assignment. Except as provided in Section 3.3 and Section 5.3, 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 o... |
13.4.1 The rights to Information, materials, Know-How and/or Patents: (a) Controlled by a Third Party permitted assignee or an Acquiror of a Party that were Controlled by such assignee or Acquiror immediately prior to such assignment, or thereafter if such Information, materials, Know-How and/or Patents become Controll... |
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 will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agree... |
13.6 Offsets. Each Party shall have the right to offset any (a) undisputed amount or (b) disputed amount once such dispute has been finally resolved pursuant to Section 13.8, in each case ((a) and (b)), owed by the other Party to such first Party under or in connection with this Agreement, including if such amount were... |
13.7 Governing Law, Jurisdiction, and Service. |
13.7.1 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 New York, United States, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or ... |
13.7.2 Service. Each Party further agrees that service of any process, summons, notice, or document by registered mail to its address set forth in Section 13.9.2 shall be effective service of process for any action, suit, or proceeding brought against it under this Agreement in any such court. |
13.8 Dispute Resolution. Except for disputes resolved by the procedures set forth in Section 2.2.4, Section 6.16 or Section 13.12, if a dispute arises between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith (a "Dispute"), it shall be resolved p... |
13.8.1 General. Any Dispute shall first be referred to the Senior Officers of the Parties, who shall confer in good faith on the resolution of the issue. 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 resol... |
13.8.2 Intellectual Property Disputes. In the event that a Dispute arises with respect the scope, inventorship, or ownership of any Patent, Trademark, or other intellectual property rights, and such Dispute cannot be resolved in accordance with Section 13.8.1, unless otherwise agreed by the Parties in writing, either P... |
13.8.3 ADR. Any ADR proceeding under this Agreement shall take place pursuant to the procedures set forth in Schedule 13.8.3. |
13.8.4 Adverse Ruling. Any determination pursuant to this Section 13.8 that a Party is in material breach of its obligations hereunder shall specify a (nonexclusive) set of actions to be taken to cure such material breach, if feasible, and any obligations of the non-breaching Party shall be tolled until the material br... |
13.8.5 Interim Relief. Notwithstanding anything herein to the contrary and without limiting Section 13.12, nothing in this Section 13.8 shall preclude either Party from seeking interim or provisional relief, including a temporary restraining order, preliminary injunction, or other interim equitable relief concerning a ... |
13.9 Notices. |
13.9.1 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 transmi... |
13.9.2 Address for Notice. |
If to AbbVie to: |
Allergan Capital S.à.r.l. 6, rue Jean Monnet L-2180 Luxembourg, Grand Duchy of Luxembourg |
with a copy (which shall not constitute notice) to: |
1 North Waukegan Road North Chicago, Illinois 60064 United States Attention: General Counsel |
If to OSE: |
OSE Immunotherapeutics 22 boulevard Benoni-Goullin 44200 Nantes, France Attention: Nicolas Poirier: CEO Anne-Laure Autret-Cornet: CFO Facsimile: nicolas.poirier@ose-immuno.com al.autret-cornet@ose-immuno.com |
13.10 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 ora... |
13.11 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... |
13.12 Equitable Relief. Each Party acknowledges and agrees that the restrictions set forth in Article 7 and Article 9 are reasonable and necessary to protect the legitimate interests of the other Party and that such other Party would not have entered into this Agreement in the absence of such restrictions, and that any... |
13.13 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... |
13.14 No Benefit to Third Parties. Except as provided in Article 11, 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. |
13.15 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 m... |
13.16 Relationship of the Parties. It is expressly agreed that OSE, 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 OSE, on the one hand, n... |
13.17 Performance by Affiliates. AbbVie may use one (1) or more of its Affiliates to perform its obligations and duties and exercise its rights hereunder; provided that each such Affiliate shall be bound by the corresponding obligations of AbbVie and AbbVie shall remain liable hereunder for the prompt payment and perfo... |
13.18 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... |
13.19 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... |
13.20 Schedules. In the event of any inconsistencies between this Agreement and any schedules or other attachments hereto, the terms of this Agreement shall control. |
13.21 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 ... |
[SIGNATURE PAGE FOLLOWS.] |
THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as of the Effective Date. |
Schedule 1.29 CMO Supply Agreements |
1. GPEx® Boost Cell Line License Agreement between Catalent Pharma Solutions, LLC and OSE Immunotherapeutics SA effective August 30, 2021. |
2. Master Development and Clinical Supply Services Agreement between OSE Immunotherapeutics SA and Catalent Pharma Solutions LLC effective November 16, 2022. |
Schedule 1.151 Transition Development Plan |
Toxicology programme: - A 4-week preliminary toxicity study in mice, OSE230 being administered twice weekly at 3-30-300 mg/kg. This study will be performed at ERBC (France). PK and ADA analyses on those mice will be performed to investigate more deeply the potential impact of ADA on PK in mice (analyses will be done at... |
- A 4-week preliminary toxicity study in rat, OSE230 being administered twice weekly at 3-30-300 mg/kg. This study will be performed at ERBC (France). PK and ADA analyses on those rats will be performed to investigate the potential impact of ADA on PK in rat (analyses will be done at OSE Immunotherapeutics, Nantes). |
- A 13-week GLP toxicity study followed by a 6-week recovery period in rat. This study will be performed at ERBC (France). |
#NAME? |
- Additional 13-week GLP toxicity study followed by a 6-week recovery period in cynomolgus monkey, OSE230 being administered weekly at 300 mg/kg. This study will be performed at ERBC (France). |
- The potential off target effect of OSE230 will be investigated using the Retrogenix cell microarray technology. This study will be performed by Charles River High Peak (UK). |
PK and ADA methods: - Development of PK and ADA methods in mouse up to 300mg/kg (not validated), developed for sample analysis of the 4-week preliminary study in mouse completed at OSE Immunotherapeutics (Nantes). |
- Development of PK and ADA methods in rat up to 300 mg/kg (not validated), developed for sample analysis of the 4-week preliminary study in rat completed at OSE Immunotherapeutics (Nantes). |
- Development and validation of PK and ADA methods in rat up to 300 mg/kg. Those methods will be developed and validated for sample analysis of the 13-week GLP toxicity study in rat, should this study be performed. Those methods will be developed and validated at QPS (Netherlands). |
- Extension of the validation for the monkey toxicity study up to 300 mg/kg. This will be done at QPS (Netherlands). |
- Development of PK and ADA methods in human. Those methods will be developed and validated at QPS (Netherlands). |
Proposed PD biomarkers for clinical phase 1 (to be discussed with AbbVie): All assays/Third Party Providers cited below are only proposals and can be subject to discussion with AbbVie. |
- On skin biopsies (after in vivo challenge with LPS in Healthy Volunteers): IHC (3 panels: neutrophils, macrophages and NETosis (e.g. CITH3)). Validation needed. The panel should be discussed with the vendor depending on their routine staining and additional markers we want to explore. The setup of the method will be ... |
RNA seq (3 gene expression signatures product-related available in human on whole blood, neutrophils and macrophages; 3 gene expression signatures linked to the mechanism of action: IL10 signatures, M1-M2 signatures and neutrophils activation). Those signatures were identified in studies performed in monkeys (internal ... |
- In serum: Determination of cytokines (no validation needed). Those methods are already available at CHDR (Netherlands) or other clinical sites. The panel of cytokines to be evaluated could be IL6, IFNγ, TNFα, IL8, IL1β, IL10, CXCL9, CXCL10, CXCL8, CCL2, CCL5, IL12, IL23, IL17, IL1 (both for safety and related to mech... |
- In plasma: OLink proteomic signature (21 proteins identified in whole blood culture) product-related could be analyzed (no validation needed). Those methods are specific and validated by O-Link company (Sweden) but can only be considered as exploratory. |
#NAME? |
ex vivo LPS challenge (multiplex cytokines). Those methods to be tested by OSE (LPS stimulation range established). The CHDR (Netherlands) has validated the cytokine expression post ex-vivo LPS challenge. The panel of cytokines to be evaluated could be: IL6, IFNγ, TNFα, IL8, IL1β, IL10, CXCL9, CXCL10, CXCL8, CCL2, CCL5... |
- On skin exudates from blister suctions (after LPS challenge in Healthy Volunteers): NETosis (validation needed). Those methods are already developed and validated by Volition (Belgium) in the plasma, but never tested in the exudates therefore requiring a pre-validation step. |
Multiplex cytokines (no validation needed). Those methods are developed by OSE and could be performed by Active Biomarkers (France). |
Vendor qualified explored CHDR (Netherlands); 2022 publication (Butters et al 2021 / CHDR LPS Challenge document). |
CMC programme: - Manufacturing and release (same DS specifications as for GMP DS batch # 22-OE01G001) of an additional 250L GMP DS batch (Catalent Madison); |
- Stability studies for new GMP DS batch (Catalent Madison); |
- Analytical method transfer and partial validation of methods for Drug Product (DP) release (Catalent Limoges); |
- Manufacturing and release (DP specifications available in the dataroom) of a GMP DP batch (Catalent Limoges); |
- Stability studies for the GMP DP batch (Catalent Limoges); |
- Compatibility & In-use stability study (Catalent Limoges); study design to be defined depending on clinical study use; |
- Manufacturing and release of a placebo batch (Catalent Limoges). |
Workplan Table for OSE230 |
All assays/Third Party Providers cited below are only proposals and can be subject to discussion with AbbVie. |
Any tech transfer to a different CRO/CMO/facility than proposed by OSE could impact overall timelines (of note, today DP manufacturing is planned at Catalent Limoges and in case of a transfer to a US site, duration and cost have not been evaluated by OSE). |
Reports and datasets supporting each work package will be delivered to AbbVie (or caused to be delivered to AbbVie) by OSE: |
Work package |
Toxicology |
Preliminary 4-week study in mice including TK and ADA assay |
Preliminary 4-week study in rat including TK and ADA assay |
SD GLP Respiratory Study in Rats |
13-week additional GLP toxicity study (high dose and control groups only) in monkey with 6-week recovery period including TK and ADA assay |
13-week GLP toxicity study in rat with 6-week recovery period, including TK and ADA assay |
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