Common use of POPIS PROJEKTU Clause in Contracts

POPIS PROJEKTU. (a) Zkoušející provede klinickou výzkumnou studii pod názvem „Otevřená studie fáze 1/2a hodnotící Fakultní nemocnice Ostrava / Prof. MUDr. Xxxxx Xxxxx, CSc. OP-104 ANCHOR Melflufen and Dexamethasone in Combination with either Bortezomib or Daratumumab in Patients with Relapsed and Relapsed-Refractory Multiple Myeloma (ANCHOR)” (the “Study”), bearing protocol number OP-104, as may be amended from time to time (the “Protocol”), the provisions of which are incorporated herein by reference. The Investigator shall perform the Study in conformance with: (i) generally accepted standards of good clinical practice, (ii) an ethical manner and in a manner that appropriately protects the safety, security, and well-being of the Study subjects and any data arising from the Study (iii) the Protocol, (iv) the FDA Form 1572, and (v) all applicable laws, rules and regulations including, but not limited to, those governing the conduct of the Study, including but not limited to Act No. 378/2007 Coll., on Pharmaceuticals, as amended, Act No. 372/2011 Coll., on Healthcare Services, as amended, Decree No 226/2008 Coll., on Good Clinical Practice and detailed conditions of clinical trials on medicinal products, as amended, and Act No. 101/2000 Coll., on Personal Data Protection, as amended. The Institution shall not reassign the conduct of the Study to another investigator without PRA’s express written consent. If the Investigator is unable to perform the duties required by this Agreement, the Institution shall promptly notify PRA in writing. If a mutually acceptable replacement is not available, this Agreement may be terminated as provided herein. Any change of the Investigator shall be covered by written Amendment to this Agreement.

POPIS PROJEKTU. (a) Zkoušející provede klinickou výzkumnou studii pod názvem „Otevřená studie fáze 1/2a hodnotící Fakultní nemocnice Ostrava / Prof. MUDr. Xxxxx Xxxxx, CSc. OP-104 ANCHOR Melflufen and Dexamethasone The Provider will permit the Investigator to conduct the clinical research study entitled “A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Combination Subjects with either Bortezomib or Daratumumab in Patients with Relapsed and RelapsedPrimary Generalized Tonic-Refractory Multiple Myeloma (ANCHOR)Clonic Seizures” (the “Study”), with an estimated number of enrolled subjects 1- 2, bearing protocol number OP-104YKP3089C033, as may be amended from time to time (the “Protocol”), the provisions of which are incorporated herein by reference. The Investigator shall perform the Study , in conformance with: (i) generally accepted standards of good clinical practice, (ii) an ethical manner and in a manner that appropriately protects the safety, security, and well-being of the Study subjects and any data arising from the Study Study, (iii) the Protocol, (iv) the FDA Form 1572any other sponsor requirements, and (v) all applicable laws, rules and regulations including, but not limited to, those governing the conduct of the Study, including but not limited local laws (in particular according to Act No. 378/2007 Coll., on Pharmaceuticals, as amended, Act No. 372/2011 Coll., on Healthcare Health Services, as amended, Act No. 110/2019 Coll., on the processing of protection personal data, as amended, and Decree No No. 226/2008 Coll., on Good Clinical Practice Practice, Regulations, Instructions), rules and detailed conditions regulations, but not limited to, those governing the conduct of clinical trials on medicinal products, as amended, and Act No. 101/2000 Coll., on Personal Data Protection, as amendedthe Study. The Institution Provider shall not reassign the conduct of the Study to another investigator without PRA’s express written consent. If the Investigator is unable to perform the duties required by this Agreement, the Institution Provider shall promptly notify PRA in writing. If a mutually acceptable replacement is not available, this Agreement may be terminated as provided herein. Any change of the Investigator shall be covered by written Amendment to this Agreement.

POPIS PROJEKTU. (a) Zkoušející provede klinickou výzkumnou studii pod názvem „Otevřená studie fáze 1/2a hodnotící Fakultní nemocnice Ostrava / Prof. MUDr. Xxxxx XxxxxThe Provider will permit the Investigator to conduct the clinical research study entitled “A Randomized, CSc. OP-104 ANCHOR Melflufen Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Dexamethasone Safety of Cenobamate Adjunctive Therapy in Combination Subjects with either Bortezomib or Daratumumab in Patients with Relapsed and RelapsedPrimary Generalized Tonic-Refractory Multiple Myeloma (ANCHOR)Clonic Seizures” (the “Study”), bearing protocol number OP-104YKP3089C025, as may be amended from time to time (the “Protocol”), the provisions of which are incorporated herein by reference. The Investigator shall perform the Study , in conformance with: (i) generally accepted standards of good clinical practice, (ii) an ethical manner and in a manner that appropriately protects the safety, security, and well-being of the Study subjects and any data arising from the Study Study, (iii) the Protocol, (iv) the FDA Form 1572any other sponsor requirements, and (v) all applicable laws, rules and regulations including, but not limited to, those governing the conduct of the Study, including but not limited local laws (in particular according to Act No. 378/2007 Coll., on Pharmaceuticals, as amended, Act No. 372/2011 Coll., on Healthcare Health Services, as amended, Decree No 226/2008 Coll., on Good Clinical Practice and detailed conditions of clinical trials on medicinal products, as amended, and Act No. 101/2000 Coll., on Personal Data ProtectionProtection personal data, as amended, and Decree No. 226/2008 Coll., on Good Clinical Practice, Regulations, Instructions), rules and regulations, but not limited to, those governing the conduct of the Study. The Institution Provider shall not reassign the conduct of the Study to another investigator without PRA’s express written consent. If the Investigator is unable to perform the duties required by this Agreement, the Institution Provider shall promptly notify PRA in writing. If a mutually acceptable replacement is not available, this Agreement may be terminated as provided herein. Any change of the Investigator shall be covered by written Amendment to this Agreement.

POPIS PROJEKTU. (a) Zkoušející provede klinickou výzkumnou studii pod názvem „Otevřená studie fáze 1/2a hodnotící Fakultní nemocnice Ostrava / Prof. MUDr. Xxxxx XxxxxThe Institution will permit the Investigator to conduct the clinical research study entitled “A Phase 3, CSc. OP-104 ANCHOR Melflufen and Dexamethasone Randomized, Double-Blind, Trial of Pamrevlumab (FG-3019) or Placebo in Combination with either Bortezomib or Daratumumab Systemic Corticosteroids in Patients Subjects with Relapsed and Relapsed-Refractory Multiple Myeloma Non- ambulatory Duchenne Muscular Dystrophy (ANCHORDMD)” (the “Study”), bearing protocol number OP-104FGCL-3019- 093, as may be amended from time to time (the “Protocol”), the provisions of which are incorporated herein by reference. The Investigator shall perform the Study , in conformance with: (i) generally accepted standards of good clinical practice, (ii) an ethical manner and in a manner that appropriately protects the safety, security, and well-being of the Study subjects and any data arising from the Study Study, (iii) the Protocol, (iv) the FDA Form 15721572 or equivalent form, and (v) all applicable laws, rules and regulations including, but not limited to, those governing the conduct of the StudyStudy and applicable medical subject privacy and data security laws and regulations, including but not limited (in particular according to Act No. 378/2007 Coll., on Pharmaceuticals, as amended, Act No. 372/2011 Coll., on Healthcare Health Services, as amended, Decree No 226/2008 Coll., on Good Clinical Practice and detailed conditions of clinical trials on medicinal products, as amended, and Act No. 101/2000 Coll., on Personal Data ProtectionProtection personal data, as amended, and Decree No. 226/2008 Coll., on Good Clinical Practice, Regulations, Instructions). The Institution shall not reassign the conduct of the Study to another investigator without PRA’s express written consent. If the Investigator is unable to perform the duties required by this Agreement, the Institution shall promptly notify PRA in writing. If a mutually acceptable replacement is not available, this Agreement may be terminated as provided herein. Any change of the Investigator shall be covered by written Amendment to this Agreement.shall

POPIS PROJEKTU. (a) Zkoušející provede klinickou výzkumnou studii pod názvem „Otevřená studie fáze 1/2a hodnotící Fakultní nemocnice Ostrava / Prof. MUDr. Xxxxx XxxxxThe Investigator will conduct the clinical research study entitled “A Phase 3, CSc. OP-104 ANCHOR Melflufen and Dexamethasone Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) versus Treatment Choice in Combination Adults with either Bortezomib Myelodysplastic Syndromes (MDS) or Daratumumab in Patients Chronic Myelomonocytic Leukemia (CMML) Previously Treated with Relapsed and Relapsed-Refractory Multiple Myeloma (ANCHOR)Hypomethylating Agents” (the “Study”), bearing protocol number OP-104SGI-110-07, as may be amended from time to time (the “Protocol”), the provisions of which are incorporated herein by reference. The Investigator shall perform the Study in conformance with: (i) generally accepted standards of good clinical practice, (ii) an ethical manner and in a manner that appropriately protects the safety, security, and well-being of the Study subjects and any data arising from the Study (iii) the Protocol, (iv) the FDA Form 1572, and (v) all applicable laws, rules and regulations including, but not limited to, those governing the conduct of the Study, including but not limited to Act No. 378/2007 Coll., on Pharmaceuticals, as amended, Act No. 372/2011 Coll., on Healthcare Services, as amended, Decree No Regulation No. 226/2008 Coll., on Good Clinical Practice and detailed conditions of clinical trials on medicinal products, as amended, and Act No. 101/2000 Coll., on Personal Data Protection, as amended. The Institution shall not reassign the conduct of the Study to another investigator without PRASponsor’s express written consent. If the Investigator is unable to perform the duties required by this Agreement, the Institution shall promptly notify PRA in writing. If a mutually acceptable replacement is not available, this Agreement may be terminated as provided herein. Any change of the Investigator shall be covered by written Amendment to this Agreement.duties

POPIS PROJEKTU. (a) Zkoušející provede klinickou výzkumnou studii pod názvem „Otevřená studie fáze 1/2a hodnotící Fakultní nemocnice Ostrava / Prof. MUDr. Xxxxx Xxxxx, CSc. OP-104 ANCHOR Melflufen and Dexamethasone in Combination with either Bortezomib or Daratumumab in Patients with Relapsed and Relapsed-Refractory Multiple Myeloma The Investigator will conduct the clinical trial entitled “A PHASE 2/3 STUDY OF ALX148 IN PATIENTS WITH ADVANCED HER2- OVEREXPRESSING GASTRIC/GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA (ANCHORASPEN-06)” (the “Study”), bearing protocol number OP-104“AT148006”, as may be amended from time to time (the “Protocol”), the provisions of which are incorporated herein by reference. The Investigator shall perform the Study in conformance with: (i) generally accepted standards of good clinical practice, (ii) an ethical manner and in a manner that appropriately protects the safety, security, and well-being of the Study subjects (the “Study Subjects”) and any data arising from the Study (iii) the Protocol, and (iv) the FDA Form 1572, and (v) all applicable local or national laws, including, but not limited to, Act No. 378/2007 Coll., on Pharmaceuticals, Act No. 372/2011 Coll., on Health Services, Regulations of the European Union and of the EU Council No. 2016/679 (the “GDPR”) and Decree No. 226 / 2008 Coll., On Good Clinical Practice, rules and regulations including, but not limited to, those governing the conduct of the Study, including but not limited to Act No. 378/2007 Coll., on Pharmaceuticals, as amended, Act No. 372/2011 Coll., on Healthcare Services, as amended, Decree No 226/2008 Coll., on Good Clinical Practice and detailed conditions of clinical trials on medicinal products, as amended, and Act No. 101/2000 Coll., on Personal Data Protection, as amendedStudy (“Applicable Laws”). The Institution Provider shall not reassign the conduct of the Study to another investigator without PRASponsor’s express written consent. If the Investigator is unable to perform the duties required by this Agreement, the Institution Provider shall promptly notify PRA Sponsor in writing. If a mutually acceptable replacement is not available, this Agreement may be terminated as provided herein. Any change of the Investigator shall be covered by written Amendment to this Agreement.