Common use of Specific Licensee Responsibilities Clause in Contracts

Specific Licensee Responsibilities. As part of the Development Program, Licensee shall: (a) Conduct, or cause to be conducted, manage and oversee formulation of the Product for use in clinical studies and for subsequent marketing; (b) Conduct, or cause to be conducted, manage and oversee all clinical studies required by the Regulatory Authorities in order to obtain Registration for the Product in the Territory; (c) Make and pursue all regulatory filings (including, without limitation, all INDs and Registration Applications), based in part on the information and documentation provided by Medistem and in part on information and data generated and obtained by Licensee in connection with the Development Program, and conduct all analysis and other support necessary with respect to the manufacture and sale of the Product in the Territory; (d) Use all commercially reasonable efforts and proceed diligently to perform such obligations, including, without limitation, by using personnel with sufficient skills and experience, together with sufficient equipment and facilities; (e) Conduct the Development Program in good scientific manner, and in compliance in all material respects with all requirements of applicable laws, rules and regulations, and all other requirements of any applicable current good clinical practice, current good laboratory practice and current good manufacturing practice to attempt to achieve the objectives of the Development Program efficiently and expeditiously; (f) Within 30 days after the end of each six-month period during the term of the Development Program and within 30 days following the expiration or termination of the Development Program, furnish at Medistem’s request reasonably detailed, written reports on all activities conducted by Licensee under the Development Program during such six-month period or the term of the Development Program, as the case may be; (g) Maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Development Program in the form required under all applicable laws and regulations. Medistem shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all such records. Medistem shall maintain such records and information contained therein in confidence in accordance with Section 8 and shall not use such records or information except to the extent otherwise permitted by this Agreement; and (h) Allow representatives of Medistem, upon reasonable notice and during normal business hours, to visit Licensee’s facilities where the Development Program is being conducted, and consult informally, during such visits and by telephone, with Licensee’s personnel performing work on the Development Program.

Specific Licensee Responsibilities. As part of the Development Program, Licensee shall: (a) Conduct, or cause to be conducted, manage and oversee formulation of the Product for use in clinical studies and for subsequent marketing; (b) Conduct, or cause to be conducted, manage and oversee all clinical studies required by the Regulatory Authorities in order to obtain Registration for the Product in the Territory; (c) Make and pursue all regulatory filings (including, without limitation, all INDs and Registration Applications), based in part on the information and documentation provided by Medistem and in part on information and data generated and obtained by Licensee in connection with the Development Program, and conduct all analysis and other support necessary with respect to the manufacture and sale of the Product in the Territory; (d) Use all commercially reasonable efforts and proceed diligently to perform such obligations, including, without limitation, by using personnel with sufficient skills and experience, together with sufficient equipment and facilities; (e) Conduct the Development Program in good scientific manner, and in compliance in all material respects with all requirements of applicable laws, rules and regulations, and all other requirements of any applicable current good clinical practice, current good laboratory practice and current good manufacturing practice to attempt to achieve the objectives of the Development Program efficiently and expeditiously; (f) Within 30 days after the end of each six6-month period during the term of the Development Program and within 30 days following the expiration or termination of the Development Program, furnish at Medistem’s request reasonably detailed, written reports on all activities conducted by Licensee under the Development Program during such six6-month period or the term of the Development Program, as the case may be; (g) Maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Development Program in the form required under all applicable laws and regulations. Medistem shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all such records. Medistem shall maintain such records and information contained therein in confidence in accordance with Section 8 and shall not use such records or information except to the extent otherwise permitted by this Agreement; and (h) Allow representatives of Medistem, upon reasonable notice and during normal business hours, to visit Licensee’s facilities where the Development Program is being conducted, and consult informally, during such visits and by telephone, with Licensee’s personnel performing work on the Development Program.

Specific Licensee Responsibilities. As part of the Development Program, Licensee shall: (a) Conduct, Conduct or cause to be conducted, manage manage, and oversee formulation growth and development of the Product for use in clinical studies applications, studies, and for subsequent marketing; (b) Conduct, or cause Market clinical treatment services relating to be conducted, manage and oversee all clinical studies required by the Regulatory Authorities in order to obtain Registration for the Product in and generate a minimum of $20,000 of monthly revenues from stem-cell related patient treatment activities involving the TerritoryProduct and under this Agreement; (c) Make Make, effect and pursue all regulatory filings (includingpursue, without limitationon behalf of Medistem, all INDs filings and Registration Applications), based in part on the information other actions with and documentation provided before Regulatory Authorities as requested by Medistem to develop or enhance Medistem’s Intellectual Property and/or to pursue and in part on information and data generated and obtained by Licensee in connection with the Development Program, and conduct all analysis and other support necessary with respect perfect INDs arising from or relating to the manufacture and sale subject matter of the Product in the Territorythis Agreement; (d) Use all commercially reasonable efforts and proceed diligently to perform such obligations, including, without limitation, by using personnel with sufficient skills and experience, together with sufficient equipment and facilities; (e) Make a good faith effort to accept patient applications for stem cell related treatment using the Product, and to treat all such applicants that conform to established medical protocols as mutually agreed between both Parties; (f) Conduct the Development Program in good scientific manner, and in compliance in all material respects with all requirements of applicable laws, rules and regulationsregulations of any Regulatory Authority or government agency, and all other requirements of any applicable current good clinical practice, current good laboratory practice and current good manufacturing practice to attempt to achieve the objectives of the Development Program efficiently and expeditiously; (fg) Maintain existing facilities and equipment in an acceptable and professional manner and be responsible for expenditures necessary to maintain such facilities and equipment; (h) Provide, hire, train, supervise, ensure the licensure of and compensate all professional and support staff as required for Licensee to perform its obligations and conduct the activities contemplated under this Agreement; (i) Within 30 days after the end of each six-month period during the term of the Development Program and within 30 days following the expiration or termination of the Development Program, furnish furnish, at Medistem’s request request, reasonably detailed, written reports on all activities conducted by Licensee under the Development Program during such six-month period or the term of the Development Program, as the case may be; (gj) Maintain Comply with all reporting, accounting, bookkeeping and record keeping and retention policies and procedures established by Medistem as reasonably required in order to manage, conduct, record and account for the operations of Licensee under this Agreement, and maintain records, in sufficient detail and in good scientific manner, which shall be complete and accurate and shall fully and properly reflect all work done and results achieved in connection with the Development Program in the form required under all applicable laws and regulations. Medistem shall have the right; (k) Maintain all necessary approvals, during normal business hours licenses and upon reasonable notice, permits with Regulatory Authorities and other government agencies as are required to inspect and copy all such records. Medistem shall maintain such records and information contained therein in confidence perform its obligations under this Agreement in accordance with Section 8 and shall not use such records or information except to the extent otherwise permitted by this Agreement; and3.4; (hl) Allow representatives of Medistem, upon reasonable notice and during normal business hours, to visit Licensee’s facilities where the Development Program is being conducted, and consult informally, during such visits and by telephone, with Licensee’s personnel performing work on the Development Program; and (m) It being understood by the Parties that all Intellectual Property relating to the Product, including any and all Inventions as may arise from, out of, as a result of or in any way in connection with the Program, is and shall always be and remain the sole property of Medistem, Licensee agrees to perform all of its obligations and agreements contained in Section 7, “Ownership; Patents,” of this Agreement.