text stringlengths 1 5.46k |
|---|
SD GLP Resp Study in Rats |
13-w additional GLP study in monkey |
1 186 860€ signed ERBC |
QPS Bioanalysis (ADA and PK) |
77 900€ +11 550€ validation of new dose, signed QPS |
10 000 € Cytokines Kit- Nantes |
PK modeling Calvagone (PK analysis) 6 600 |
Total 1 292 910€ revised |
Off target assessment |
13-w GLP rat study |
+ 250 k€ bioanalysis at QPS |
378 530€ revised (number of animals reduced 148 vs 250 confirmed) + 6K€ QPS validation PK ADA 102 930€ (60 370+ 42 560) + bioanalysis 78090 € |
Total revised 565,590€ |
PHASE 1 HUMAN PK/BIOMARKERS |
Total 1,200 k€ still estimated |
PK and ADA methods |
Cytokine and biomarkers assessment |
CMC |
Additional GMP 250L DS batch |
Catalent Madison 1 576 000$ 1 321 000$ already paid Additional stability cost updated |
DP-related activities (production, analytical method validation, stability, Placebo) |
TOTAL |
Appendix A: CMC Documentations |
Item # |
1 |
2 |
3 |
4 |
5 |
6 |
³ Work may be performed at AbbVie or a CMO(s) selected by AbbVie. |
Schedule 10.2.1 Existing Patents |
List of Patents |
[Table with patent information including IP family references, filing numbers, dates, etc.] |
Schedule 10.2.10 Third Party Agreements |
ACTIVE BIOMARKER |
1. Amendment 1 to the Project Order 1 between OSE Immunotherapeutics and Active Biomarkers, effective as from June 15th, 2022 (executed) |
2. Amendment 2 to the Project Order 1 between OSE Immunotherapeutics and Active Biomarkers, effective as from July 18th, 2022 (executed) |
3. Project Order 1 between OSE Immunotherapeutics and Active Biomarkers, as from May 3rd, 2022 (executed) |
AGRO-BIO |
4. Contract for the provision of services (Contrat de prestation de services) between OSE Immunotherapeutics and Agro-Bio, effective as from August 11, 2023 (French language) (executed) |
5. Contract for the provision of services (Contrat de prestation de services) between OSE Immunotherapeutics and Agro-Bio, effective as from June 9, 2022 (French language) (executed) |
6. Contract for the provision of services between OSE Immunotherapeutics and Agro-Bio, effective as from June 9, 2022 (translation from French) |
7. Contract for the provision of services between OSE Immunotherapeutics and Agro-Bio, effective as from August 11, 2023 (translation from French) |
Ambiotis |
8. Patent Assignment Agreement (Contrat de Cession de Droits sur les brevets) between OSE Immunotherapeutics and Ambiotis, effective as from April 3, 2018 - in French |
9. Patent Assignment Agreement between OSE Immunotherapeutics and Ambiotis, effective as from April 3, 2018 - Translation from French |
ANAPATH |
10. Services Agreement between OSE Immunotherapeutics and AnaPath Research S.A.U, effective as from April 5th, 2022 (executed) |
B&S |
11. Engagement letter (Lettre de mission) OSE Immunotherapeutics - Accompagnement dans la définition et la mise en œuvre opérationnelle de la stratégie PI - January 1st, 2023 (French language) (executed) |
12. Engagement letter OSE Immunotherapeutics - Support in the definition and operational implementation of the IP strategy - January 1st, 2023 (translation from French) |
BIOTEM |
13. Contract for the provision of services (Contrat de prestation de services) between OSE Immunotherapeutics and Biotem, effective as from July 31, 2020 (French language) (executed) |
14. Contract for the provision of services between OSE Immunotherapeutics and Biotem, effective as from July 31, 2020 (translation from French) |
CALVAGONE |
15. Consulting Agreement between OSE Immunotherapeutics and Calvagone Sarl, effective as from April 27th, 2021 (executed) |
16. Amendment 2 to the Consulting Agreement between OSE Immunotherapeutics and Calvagone Sarl, effective as from June 13th, 2022 (executed) |
17. Services Agreement between OSE Immunotherapeutics and Calvagone SAS, effective as from December 23rd, 2022 (executed) |
18. Services Agreement between OSE Immunotherapeutics and Calvagone SAS, effective as from September 26, 2023 (executed) |
19. Services Agreement between OSE Immunotherapeutics and Calvagone SAS, effective as from January 10, 2024 (executed) |
CATALENT FRANCE LIMOGES |
20. Customized Solution for OSE Immunotherapeutics - Clinical Program Phase 1 for OSE 230 Product - 9 March 2022 (executed) |
21. Solution for OSE Immunotherapeutics - Cancellation and Postponement fees for OSE 230 Product - 23 March 2023 (executed) |
CATALENT MADISON US |
22. Statement of Work (SOW) - QTE-9193180 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - April 28, 2021 |
23. Statement of Work (SOW) - QTE -9194626- OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - June 4, 2021 |
24. Statement of Work (SOW) - QTE 9188753- OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - September 29, 2021 |
25. Statement of Work (SOW) - QTE-9201531 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - November 10, 2021 |
26. Statement of Work (SOW) - QTE-9209608 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - July 21, 2022 |
27. Statement of Work (SOW) - QTE-9188753 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - September 26, 2022 |
28. Statement of Work (SOW) - QTE-9209608 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - October 28, 2022 |
29. Statement of Work (SOW) - QTE-9209608 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - December 13, 2022 |
30. Statement of Work (SOW) - QTE-9241196 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - August 4, 2023 |
31. Statement of Work (SOW) - QTE-9188753 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - November 30, 2021 |
32. Statement of Work (SOW) - QTE-9241196 - OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - September 14, 2023 |
33. Master Development and Clinical Supply Services Agreement between OSE Immunotherapeutics and Catalent, effective as from November 16, 2022 (executed) |
34. GPEx® Boost Cell Line License Agreement between OSE Immunotherapeutics and Catalent, effective as from August 30, 2021 (executed) |
35. Statement of Work (SOW) - QTE-9241196_QAR02- OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 – January 17, 2024 |
36. Statement of Work (SOW) - QAR06 - QTE-9248010- OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - December 6, 2023 |
37. Statement of Work (SOW) - QAR04.02_QTE-9188754- OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 - December 13, 2023 |
38. Statement of Work (SOW) -QAR05 - QTE-9246109- OSE Immunotherapeutics SA - Catalent Pharma Solutions LLC - OSE 230 – November 9, 2023 |
CYNBIOSE |
39. Services Agreement between OSE Immunotherapeutics and Cynbiose, effective as from July 4th, 2022 (executed) |
40. Amendment 1 to Services Agreement between OSE Immunotherapeutics and Cynbiose, effective as from October 6th, 2022 (executed) |
ERBC |
41. Project Order 2 OSE-230 GLP Tox Study in monkey between OSE Immunotherapeutics and ERBC, effective as from August 2nd, 2022 (executed) |
42. Project Order 3 OSE-230 DRF Study and Toxicity Study between OSE Immunotherapeutics and ERBC, effective as from November 17th, 2022 (executed) |
43. ERBC - Credit Note to Quotation 22AFQ-V2 - OSE 230 - OSE Immunotherapeutics - 21 November 2022 (executed) |
44. Amendment 2 Project Order 2 - OSE-230 GLP Tox Study in monkey between OSE Immunotherapeutics and ERBC, effective as from March 20th, 2023 (executed) |
45. Project Order 4 OSE-230 DRF Study and Toxicity Study between OSE Immunotherapeutics and ERBC Baugy France, effective as from August 4th, 2023 (executed) |
46. Amendment 1 Project Order 4 - OSE-230 DRF Study and Toxicity Study between OSE Immunotherapeutics and ERBC, effective as from March 20th, 2023 (executed) |
47. Project Order 5 OSE-230 Rat Toxicity Study between OSE Immunotherapeutics and ERBC Baugy France, effective as from October 11th, 2023 (executed) |
48. ERBC Proposal 22AFQ Amendment 4 - OSE Immunotherapeutics - 7 November 2023 (executed) |
49. Master Service Agreement between OSE Immunotherapeutics and ERBC, effective as from January 24th, 2020 (executed) |
50. ERBC_Proposal__23BDE_V2_OSE Respiratory safety pharmacology in Rat between OSE Immunotherapeutics and ERBC, effective as from December 1st, 2023 (executed) |
EVITRIA |
51. Expression and Purification of Monoclonal Antibodies – Evitria Proposal No. 702282 - 9 September 2022 |
52. Design and Piloting of Monoclonal Antibodies with Larger Scale Expression / Purification - Evitria Proposal No. 800644 - 27 November 2019 |
53. Expression and Purification of Monoclonal Antibodies - Evitria Proposal No. 902231 - 7 January 2021 (executed) |
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