Common use of Product Candidates Clause in Contracts

Product Candidates. (a) Each of the Company’s products and product candidates is being, and at all times has been, developed, tested, manufactured, processed, labeled, stored, transported and distributed, as applicable, in compliance in all material respects with all applicable Laws, including those requirements relating to current good manufacturing practices, good laboratory practices and good clinical practices. Nothing in this Section 2.29 relates to privacy, data protection, or data security with respect to Personal Information, which are addressed exclusively in Section 2.26. (b) The pre-clinical and clinical trials (including any post-marketing studies) conducted by or on behalf of the Company were, and if still pending, are, being conducted in all material respects in accordance with all clinical protocols, informed consents and applicable Laws. The Company retains exclusive ownership of all data resulting from pre-clinical and clinical trials (including any post-marketing studies) conducted by or on behalf of the Company. The Company has not been notified by the FDA or any other Governmental Body of any restriction on the pre-clinical or clinical trials conducted or currently being conducted by or on behalf of the Company. The descriptions of, protocols for, and data and other results of, the pre-clinical and clinical trials conducted or currently being conducted by or on behalf of the Company that have been provided to Parent are true, correct and complete. (c) The Company has fulfilled and performed its obligations under each FDA/EMA Registration in all material respects, and no material event has occurred or condition or state of facts exists which would reasonably constitute a breach or default or would cause revocation, suspension, or termination of any such FDA/EMA Registration. No loss or expiration of any FDA/EMA Registration is pending or, to the Knowledge of the Company, threatened, other than expiration of any FDA/EMA Registration in accordance with the terms thereof, and there is no circumstance that would reasonably be expected to cause such FDA/EMA Registration to not be renewable upon expiration to the extent permitted by law, as needed. To the Knowledge of the Company, any third-party that is a supplier, manufacturer, or contractor for the Company is in material compliance with all FDA/EMA Registrations and the authorizations, approvals, licenses, permits, certificates, or exemptions (including, without limitation, pre-market approval applications, pre-market notifications, investigational new drug applications, new drug applications, biologic license applications, manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals or their foreign equivalent) held by the Company that are required for, among other things, the research, development, manufacture, processing, labeling, distribution, marketing, storage, transportation, use, sale and provision of the products and services of the Company, of any comparable Governmental Body. (d) Section 2.29(d) of the Disclosure Schedule sets forth a true, correct and complete list of all of the Company’s products and product candidates in clinical trial or development as of the date hereof, noting, where applicable, (i) the phase of clinical trial or development each product or product candidate is in, and (ii) those products or product candidates where FDA and/or other regulatory approval, including foreign approvals, has been applied for and/or received, and listing the application made and/or the approval or decision thereon obtained. The Company has provided to Parent true, correct and complete copies of, without limitation, (A) any investigational new drug applications or new drug applications submitted to the FDA or any other Governmental Body by or on behalf of the Company, including any supplements thereto, (B) all final study results and/or reports relating to products or product candidates, (C) all material correspondence to or from the FDA or other Governmental Bodies, including meeting minutes and records of material contacts, (D) all documents in the Company’s possession related to inspections by the FDA or other Governmental Bodies, and (E) all adverse drug experience reports obtained or otherwise received by the Company from any source with respect to the products or product candidates.

Product Candidates. (a) Each of the Company’s products and product candidates is being, and at all times has been, developed, tested, manufactured, processed, labeled, stored, transported and distributed, as applicable, in compliance in all material respects with all applicable Laws, including those requirements relating to current good manufacturing practices, good laboratory practices and good clinical practices. Nothing in this Section 2.29 relates to privacy, data protection, or data security with respect to Personal Information, which are addressed exclusively in Section 2.26. (b) The pre-clinical and clinical trials (including any post-marketing studies) conducted by or on behalf of the Company were, and if still pending, are, being conducted in all material respects in accordance with all clinical protocols, informed consents and applicable Laws. The Company retains exclusive ownership of all data resulting from pre-clinical and clinical trials (including any post-marketing studies) conducted by or on behalf of the Company. The Company has not been notified by the FDA or any other Governmental Body of any restriction on the pre-clinical or clinical trials conducted or currently being conducted by or on behalf of the Company. The descriptions of, protocols for, and data and other results of, the pre-clinical and clinical trials conducted or currently being conducted by or on behalf of the Company that have been provided to Parent the Purchaser are true, correct and complete. (c) The Company has fulfilled and performed its obligations under each FDA/EMA FDA Registration in all material respects, and no material event has occurred or condition or state of facts exists which would reasonably constitute a breach or default or would cause revocation, suspension, limitation or termination of any such FDA/EMA FDA Registration or would result in any other impairment of the rights of the holder of any such FDA Registration. No loss or expiration of any FDA/EMA FDA Registration is pending or, to the Knowledge of the Company, threatened, other than expiration of any FDA/EMA FDA Registration in accordance with the terms thereof, and there is no circumstance that would reasonably be expected to cause such FDA/EMA FDA Registration to not be renewable upon expiration to the extent permitted by law, as needed. To the Knowledge of the Company, any third-party that is a supplier, manufacturer, or contractor for the Company is in material compliance with all FDA/EMA FDA Registrations and the authorizations, approvals, licenses, permits, certificates, or exemptions (including, without limitation, pre-market approval applications, pre-market notifications, investigational new drug applications, new drug applications, biologic license applications, manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals or their foreign equivalent) held by the Company that are required for, among other things, the research, development, manufacture, processing, labeling, distribution, marketing, storage, transportation, use, sale and provision of the products and services of the Company, of any comparable Governmental Body. (d) Section 2.29(d2.25(d) of the Disclosure Schedule sets forth a true, correct and complete list of all of the Company’s products and product candidates in clinical trial or development as of the date hereofcandidates, noting, where applicable, (i) the phase as of the date of this Agreement of clinical trial or development each product or product candidate is in, and (ii) those products or product candidates where FDA and/or other regulatory approval, including foreign approvals, has been applied for and/or received, and listing the application made and/or the approval or decision thereon obtained. The Company has provided will, within 30 days of the date of this Agreement, provide to Parent the Purchaser true, correct and complete copies of, without limitation, (A) any investigational new drug applications or new drug applications submitted to the FDA or any other Governmental Body by or on behalf of the 21 Company, including any supplements thereto, (B) all final study results and/or reports relating to products or product candidates, (C) all material correspondence to or from the FDA or other Governmental Bodies, including meeting minutes and records of material contacts, (D) all documents in the Company’s possession related to inspections by the FDA or other Governmental Bodies, and (E) all information relating to adverse drug experience reports experiences obtained or otherwise received by the Company from any source with respect to the products or product candidates.

Product Candidates. (a) Each of the CompanyCureDM’s clinical-stage products and product candidates is are being, and at all times has have been, developed, tested, manufactured, processed, labeled, stored, transported and distributed, as applicable, in compliance in all material respects with all applicable Lawslaws, including those requirements relating to current good manufacturing practices, good laboratory practices and good clinical practices. Nothing in this Section 2.29 relates to privacy, data protection, or data security with respect to Personal Information, which are addressed exclusively in Section 2.26practices applicable at the appropriate times. (b) The pre-clinical and clinical trials (including any post-marketing studies) conducted by or on behalf of the Company CureDM were, and if still pending, are, being conducted in all material respects in accordance with all applicable clinical protocols, informed consents and applicable Lawslaws. The Company retains exclusive ownership of all data resulting from pre-clinical and clinical trials (including any post-marketing studies) conducted by or on behalf of the Company. The Company CureDM has not been notified by the FDA or any other Governmental Body comparable governmental body of any restriction on the pre-clinical or clinical trials conducted or currently being conducted by or on behalf of CureDM. Schedule 2.24(b), contains a descriptions of, protocols for, and data and other results of, the Companypre-clinical and clinical trials conducted or currently being conducted by or on behalf of CureDM that have been provided to BTHE which includes the location of the registered file and the identification of the party that has verified such protocol and data. The descriptions of, protocols for, and data and other results of, the pre-clinical and clinical trials conducted or currently being conducted by or on behalf of the Company CureDM that have been provided to Parent BTHE are true, correct and complete. (c) The Company has CureDM has, where required, fulfilled and performed its obligations under each FDA/EMA Registration FDA registration (collectively, the “CureDM FDA Registrations” and each a “CureDM FDA Registration”) in all material respects, and and, to the knowledge of CureDM, no material event has occurred or condition or state of facts exists which would reasonably that could constitute a breach or default or would could cause revocation, suspension, limitation or termination of any such FDA/EMA CureDM FDA Registration or would reasonably be expected to result in any other material impairment of the rights of the holder of any such CureDM FDA Registration. No loss or expiration of any FDA/EMA CureDM FDA Registration is pending or, to the Knowledge knowledge of the CompanyCureDM, threatened, other than expiration of any FDA/EMA CureDM FDA Registration in accordance with the terms thereof, and and, to the knowledge of CureDM, there is no circumstance that would could reasonably be expected to cause such FDA/EMA CureDM FDA Registration to not be renewable upon expiration to the extent permitted by law, as needed. To the Knowledge knowledge of the CompanyCureDM, any third-party that is a supplier, manufacturer, or contractor for the Company CureDM is in material compliance with all FDA/EMA CureDM FDA Registrations and the authorizations, approvals, licenses, permits, certificates, or exemptions (including, without limitation, pre-market approval applications, pre-market notifications, investigational new drug applications, new drug applications, biologic license applications, manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals or their foreign equivalent) held by the Company CureDM that are required for, among other things, the research, development, manufacture, processing, labeling, distribution, marketing, storage, transportation, use, sale and provision of the products and services of the CompanyCureDM, of any comparable Governmental Bodygovernmental body. (d) Section 2.29(dSchedule 2.24(d) of the Disclosure Schedule sets forth a true, correct and complete list of all of the CompanyCureDM’s products and product candidates in clinical trial or development as of the date hereofcandidates, noting, where applicable, (i) the phase of clinical trial or development each product or product candidate is in, and (ii) those products or product candidates where FDA and/or other regulatory approval, including foreign approvals, has been applied for and/or received, and listing the application made and/or the approval or decision thereon obtained. The Company CureDM has provided made available to Parent BTHE true, correct and complete electronic copies of, without limitation, of (A) any investigational new drug applications or new drug applications submitted to the FDA or any other Governmental Body governmental body by or on behalf of the CompanyCureDM, including any supplements thereto, (B) all final study results and/or reports relating to products or product candidates, (C) all material correspondence to or from CureDM (or its investigators) and the FDA or other Governmental Bodiescomparable governmental bodies, including meeting minutes and records of material contacts, (D) all documents in the CompanyCureDM’s possession related to inspections by the FDA or other Governmental Bodiescomparable governmental bodies, and (E) all information relating to adverse drug experience reports experiences obtained or otherwise received by the Company CureDM from any source with respect to the CureDM’s products or product candidates.

Product Candidates. (a) Each of the The Company’s biologic products and product candidates is clinical-stage products are being, and at all times has have been, developed, tested, manufactured, processed, labeled, stored, transported and distributed, as applicable, in compliance in all material respects with all applicable Laws, including those requirements relating to current good manufacturing practices, good laboratory practices and good clinical practices. Nothing in this Section 2.29 relates to privacy, data protection, or data security with respect to Personal Information, which are addressed exclusively in Section 2.26practices applicable at the appropriate times. (b) The pre-clinical and clinical trials (including any post-marketing studies) conducted by or on behalf of the Company were, and if still pending, are, being conducted in all material respects in accordance with all applicable clinical protocols, informed consents and applicable Laws. The Company retains exclusive ownership of all data resulting from pre-clinical and clinical trials (including any post-marketing studies) conducted by or on behalf of the Company. The Company has not been notified by the FDA FDA, the EMA or any other comparable Governmental Body of any restriction on the pre-clinical or clinical trials conducted or currently being conducted by or on behalf of the Company. The descriptions of, protocols for, and data and other results of, the pre-clinical and clinical trials conducted or currently being conducted by or on behalf of the Company that have been provided to Parent the Purchaser are true, correct and complete. (c) The Company has where required fulfilled and performed its obligations under each FDA/FDA Registration, EMA Registration, and MHRA Registration in all material respects, and and, to the Knowledge of the Company, no material event has occurred or condition or state of facts exists which would reasonably could constitute a breach or default or would could cause revocation, suspension, limitation or termination of any such FDA/FDA Registration, EMA Registration, or MHRA Registration or could result in any other material impairment of the rights of the holder of any such FDA Registration, EMA Registration, or MHRA Registration. No loss or expiration of any FDA/FDA Registration, EMA Registration, or MHRA Registration is pending or, to the Knowledge of the Company, threatened, other than expiration of any FDA/FDA Registration, EMA Registration, or MHRA Registration in accordance with the terms thereof, and and, to the Knowledge of the Company, there is no circumstance that would could reasonably be expected to cause such FDA/FDA Registration, EMA Registration, or MHRA Registration to not be renewable upon expiration to the extent permitted by lawLaw, as needed. To the Knowledge of the Company, any third-party that is a supplier, manufacturer, or contractor for the Company is in material compliance with all FDA/FDA Registrations, EMA Registrations, and MHRA Registrations and the authorizations, approvals, licenses, permits, certificates, or exemptions (including, without limitation, pre-market approval applications, pre-market notifications, investigational new drug applications, new drug applications, biologic license applications, manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals or their foreign equivalent) held by the Company that are required for, among other things, the research, development, manufacture, processing, labeling, distribution, marketing, storage, transportation, use, sale and provision of the products and services of the Company, of any comparable Governmental Body. (d) Section 2.29(d2.35(d) of the Disclosure Schedule sets forth a true, correct and complete list of all of the Company’s products and product candidates in clinical trial or development as of the date hereofcandidates, noting, where applicable, (i) the phase of clinical trial or development each product or product candidate is in, and (ii) those products or product candidates where FDA FDA, EMA and/or other regulatory approval, including foreign approvals, has been applied for and/or received, and listing the application made and/or the approval or decision thereon obtained. The Company has provided to Parent the Purchaser true, correct and complete copies of, without limitation, of (A) any investigational new drug applications or new drug applications submitted to the FDA FDA, the EMA or any other Governmental Body by or on behalf of the Company, including any supplements thereto, (B) all final study results and/or reports relating to products or product candidates, (C) all material correspondence to or from the FDA Company (or its investigators) and the FDA, the EMA or other comparable Governmental Bodies, including meeting minutes and records of material contacts, (D) all documents in the Company’s possession related to inspections by the FDA FDA, the EMA or other Governmental Bodies, and (E) all information relating to adverse drug experience reports experiences obtained or otherwise received by the Company from any source with respect to the products or product candidates.

Product Candidates. (a) Each of the Company’s products and product candidates is being, and at all times has been, developed, tested, manufactured, processed, labeled, stored, transported and distributed, as applicable, in compliance in all material respects with all applicable Laws, including those requirements relating to current good manufacturing practices, good laboratory practices and good clinical practices. Nothing in this Section 2.29 relates to privacy, data protection, or data security with respect to Personal Information, which are addressed exclusively in Section 2.26. (b) The pre-clinical and clinical trials (including any post-marketing studies) conducted by or on behalf of the Company were, and if still pending, are, being conducted in all material respects in accordance with all clinical protocols, informed consents and applicable Laws. The Company retains exclusive ownership of all data resulting from pre-clinical and clinical trials (including any post-marketing studies) conducted by or on behalf of the Company. The Company has not been notified by the FDA or any other Governmental Body of any restriction on the pre-clinical or clinical trials conducted or currently being conducted by or on behalf of the Company. The descriptions of, protocols for, and data and other results of, the pre-clinical and clinical trials conducted or currently being conducted by or on behalf of the Company that have been provided to Parent the Purchaser are true, correct and complete. (c) The Company has fulfilled and performed its obligations under each FDA/EMA FDA Registration in all material respects, and no material event has occurred or condition or state of facts exists which would reasonably constitute a breach or default or would cause revocation, suspension, limitation or termination of any such FDA/EMA FDA Registration or would result in any other impairment of the rights of the holder of any such FDA Registration. No loss or expiration of any FDA/EMA FDA Registration is pending or, to the Knowledge of the Company, threatened, other than expiration of any FDA/EMA FDA Registration in accordance with the terms thereof, and there is no circumstance that would reasonably be expected to cause such FDA/EMA FDA Registration to not be renewable upon expiration to the extent permitted by law, as needed. To the Knowledge of the Company, any third-party that is a supplier, manufacturer, or contractor for the Company is in material compliance with all FDA/EMA FDA Registrations and the authorizations, approvals, licenses, permits, certificates, or exemptions (including, without limitation, pre-market approval applications, pre-market notifications, investigational new drug applications, new drug applications, biologic license applications, manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals or their foreign equivalent) held by the Company that are required for, among other things, the research, development, manufacture, processing, labeling, distribution, marketing, storage, transportation, use, sale and provision of the products and services of the Company, of any comparable Governmental Body. (d) Section 2.29(d2.33(d) of the Disclosure Schedule sets forth a true, correct and complete list of all of the Company’s products and product candidates in clinical trial or development as of the date hereofcandidates, noting, where applicable, (i) the phase of clinical trial or development each product or product candidate is in, and (ii) those products or product candidates where FDA and/or other regulatory approval, including foreign approvals, has been applied for and/or received, and listing the application made and/or the approval or decision thereon obtained. The Company has provided to Parent the Purchaser true, correct and complete copies of, without limitation, (A) any investigational new drug applications or new drug applications submitted to the FDA or any other Governmental Body by or on behalf of the Company, including any supplements thereto, (B) all final study results and/or reports relating to products or product candidates, (C) all material correspondence to or from the FDA or other Governmental Bodies, including meeting minutes and records of material contacts, (D) all documents in the Company’s possession related to inspections by the FDA or other Governmental Bodies, and (E) all information relating to adverse drug experience reports experiences obtained or otherwise received by the Company from any source with respect to the products or product candidates.

Product Candidates. (a) Each of the Company’s products and product candidates is being, and at all times has been, developed, tested, manufactured, processed, labeled, stored, transported and distributed, as applicable, in compliance in all material respects with all applicable Laws, including those requirements relating to current good manufacturing practices, good laboratory practices and good clinical practices. Nothing in this Section 2.29 relates to privacy, data protection, or data security with respect to Personal Information, which are addressed exclusively in Section 2.26. (b) The pre-clinical and clinical trials (including any post-marketing studies) conducted by or on behalf of the Company were, and if still pending, are, being conducted in all material respects in accordance with all clinical protocols, informed consents and applicable Laws. The Company retains exclusive ownership of all data resulting from pre-clinical and clinical trials (including any post-marketing studies) conducted by or on behalf of the Company. The Company has not been notified by the FDA or any other Governmental Body of any restriction on the pre-clinical or clinical trials conducted or currently being conducted by or on behalf of the Company. The descriptions of, protocols for, and data and other results of, the pre-clinical and clinical trials conducted or currently being conducted by or on behalf of the Company that have been provided to Parent the Purchaser are true, correct and complete. (c) The Company has fulfilled and performed its obligations under each FDA/EMA FDA Registration in all material respects, and no material event has occurred or condition or state of facts exists which would reasonably constitute a breach or default or would cause revocation, suspension, limitation or termination of any such FDA/EMA FDA Registration or would result in any other impairment of the rights of the holder of any such FDA Registration. No loss or expiration of any FDA/EMA FDA Registration is pending or, to the Knowledge of the Company, threatened, other than expiration of any FDA/EMA FDA Registration in accordance with the terms thereof, and there is no circumstance that would reasonably be expected to cause such FDA/EMA FDA Registration to not be renewable upon expiration to the extent permitted by law, as needed. To the Knowledge of the Company, any third-party that is a supplier, manufacturer, or contractor for the Company is in material compliance with all FDA/EMA FDA Registrations and the authorizations, approvals, licenses, permits, certificates, or exemptions (including, without limitation, pre-market approval applications, pre-market notifications, investigational new drug applications, new drug applications, biologic license applications, manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals or their foreign equivalent) held by the Company that are required for, among other things, the research, development, manufacture, processing, labeling, distribution, marketing, storage, transportation, use, sale and provision of the products and services of the Company, of any comparable Governmental Body. (d) Section 2.29(d2.25(d) of the Disclosure Schedule sets forth a true, correct and complete list of all of the Company’s products and product candidates in clinical trial or development as of the date hereofcandidates, noting, where applicable, (i) the phase as of the date of this Agreement of clinical trial or development each product or product candidate is in, and (ii) those products or product candidates where FDA and/or other regulatory approval, including foreign approvals, has been applied for and/or received, and listing the application made and/or the approval or decision thereon obtained. The Company has provided will, within 30 days of the date of this Agreement, provide to Parent the Purchaser true, correct and complete copies of, without limitation, (A) any investigational new drug applications or new drug applications submitted to the FDA or any other Governmental Body by or on behalf of the Company, including any supplements thereto, (B) all final study results and/or reports relating to products or product candidates, (C) all material correspondence to or from the FDA or other Governmental Bodies, including meeting minutes and records of material contacts, (D) all documents in the Company’s possession related to inspections by the FDA or other Governmental Bodies, and (E) all information relating to adverse drug experience reports experiences obtained or otherwise received by the Company from any source with respect to the products or product candidates.