Diligence Requirements. COMPANY shall use diligent efforts, or shall cause its AFFILIATES to use diligent efforts, to develop LICENSED PRODUCTS or LICENSED PROCESSES to identify DISCOVERY PRODUCTS and to introduce THERAPEUTIC PRODUCTS into the commercial market; thereafter, COMPANY or its AFFILIATES shall make THERAPEUTIC PRODUCTS reasonably available to the public. Specifically, COMPANY or AFFILIATE shall fulfill the following obligations: (a) Within **** months after the EFFECTIVE DATE, COMPANY shall furnish THE PARTIES with a written research and development plan describing the major tasks to be achieved in order to bring to develop a SCREENING ASSAY, specifying the number of staff and other resources to be devoted to such commercialization effort. (b) Within **** days after the end of each calendar year, COMPANY shall furnish M.I.T. with a written report (consistent with Section 5.1(a)) on the progress of its efforts during the immediately preceding calendar year to develop and commercialize DISCOVERY PRODUCTS and THERAPEUTIC PRODUCTS using LICENSED PRODUCTS and/or LICENSED PROCESSES in the SCREENING ASSAY. The report shall also contain a discussion of intended efforts and sales projections for THERAPEUTIC PRODUCTS for the year in which the report is submitted. (c) For each year following the EFFECTIVE DATE, COMPANY or AFFILIATES or SUBLICENSEES shall expend at least the amounts set forth below on research using LICENSED PRODUCT and/or LICENSED PROCESS in the SCREENING ASSAY. Such amounts may be expended by COMPANY or AFFILIATES or SUBLICENSEES, or by research partners. 2013 $100,000 2014 $600,000 2015 $850,000 2016 $1,000,000 and every year thereafter until the initiation of a clinical trial - $2,000,000 (d) By **** months after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall have a working model of a SCREENING ASSAY using LICENSED PRODUCT and/or LICENSED PROCESS. (e) By **** years after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall identify a DISCOVERY PRODUCT. (f) Prior to the end of 20**, COMPANY shall advance at least **** new DISCOVERY PRODUCT to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies. Furthermore, prior to the end of 20**, COMPANY shall advance at least **** additional new DISCOVERY CANDIDATES to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies. (g) COMPANY or an AFFILIATE or a SUBLICENSEE shall file an IND for a THERAPEUTIC PRODUCT by January 1, 20**. (h) COMPANY or an AFFILIATE or a SUBLICENSEE shall enroll first subject in a Phase I (or equivalent) trial for a THERAPEUTIC PRODUCT by January 1, 20**. (i) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase II trial for a THERAPEUTIC PRODUCT by January 1, 20**. (j) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase III trial for a THERAPEUTIC COMPOUND by January 1, 20**. (k) COMPANY or an AFFILIATE or a SUBLICENSEE shall make a FIRST COMMERCIAL SALE of THERAPEUTIC PRODUCT by January 1, 20**. In the event that THE PARTIES determines that COMPANY (or an AFFILIATE or SUBLICENSEE) has failed to fulfill any of its obligations under this Section, then THE PARTIES may treat such failure as a breach in accordance with Section 12.3(b). Notwithstanding the foregoing, in the event that COMPANY anticipates a failure to meet an obligation set forth in this Section, COMPANY will promptly advise THE PARTIES in writing, and representatives of each party will meet to review the reasons for anticipated failure (taking into account delays beyond the reasonable control of the COMPANY, including action, inaction or delay by the FDA or any comparable regulatory agency and adverse developments with respect to the safety or efficacy of product candidates) and discuss in good faith a potential revision to the diligence schedule. COMPANY and THE PARTIES will enter into a written amendment to the AGREEMENT with respect to any mutually agreed upon change(s) to the relevant obligation(s).
Appears in 3 contracts
Samples: Exclusive Patent License Agreement (MetaStat, Inc.), Exclusive Patent License Agreement (MetaStat, Inc.), Exclusive Patent License Agreement (MetaStat, Inc.)
Diligence Requirements. COMPANY shall use diligent efforts, or shall cause its AFFILIATES to use diligent efforts, to develop LICENSED PRODUCTS or LICENSED PROCESSES to identify DISCOVERY PRODUCTS and to introduce THERAPEUTIC LICENSED PRODUCTS or LICENSED PROCESSES into the commercial market; thereafter, COMPANY or its AFFILIATES shall make THERAPEUTIC LICENSED PRODUCTS or LICENSED PROCESSES reasonably available to the public. Specifically, COMPANY or AFFILIATE shall fulfill the following obligations:
(a) Within **** months after the EFFECTIVE DATE, COMPANY shall furnish THE PARTIES with a written research and development plan describing the major tasks to be achieved in order to bring to develop market a SCREENING ASSAYLICENSED PRODUCT or a LICENSED PROCESS in the FIELD, specifying the number of staff and other resources to be devoted to such commercialization effort.
(b) Within **** days after the end of each calendar year, COMPANY shall furnish M.I.T. THE PARTIES with a written report (consistent with Section 5.1(a)) on the progress of its efforts during the immediately preceding calendar year to develop and commercialize DISCOVERY PRODUCTS and THERAPEUTIC PRODUCTS using LICENSED PRODUCTS and/or or LICENSED PROCESSES in the SCREENING ASSAYFIELD. The report shall also contain a discussion of intended efforts and sales projections for THERAPEUTIC PRODUCTS for the year in which the report is submitted.
(c) For each year following the EFFECTIVE DATEDATE until a first commercial sale of a LICENSED PRODUCT in the FIELD, COMPANY or AFFILIATES or SUBLICENSEES shall expend at least the amounts set forth below on research using toward the development of LICENSED PRODUCTS in each calendar year and ending with the first commercial sale of a LICENSED PRODUCT and/or LICENSED PROCESS in the SCREENING ASSAYFIELD. Such amounts may be expended by COMPANY or AFFILIATES or SUBLICENSEES, or by research partners. 2013 $100,000 50,000 2014 $600,000 150,000 2015 $850,000 400,000 2016 $1,000,000 and every year thereafter until the initiation of a clinical trial - $2,000,000
(d) By Within **** months after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall have initiate studies using human patient-derived samples for the purposes of discovering a working model of a SCREENING ASSAY using LICENSED PRODUCT and/or or LICENSED PROCESS in the FIELD.
(e) Within **** after the EFFECTIVE DATE, COMPANY (or an AFFILIATE) shall identify an IDENTIFIED PRODUCT to develop for use in conjunction with a LICENSED PRODUCT or LICENSED PROCESS.
(ef) By Within **** years after of the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall identify a DISCOVERY PRODUCT.
(f) Prior to the end of 20**, COMPANY shall advance at least **** new DISCOVERY PRODUCT to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology initiate clinical studies in support of an Investigational New Drug application (“IND”) (obtaining regulatory approval of a LICENSED PRODUCT or equivalent) for human studies. Furthermore, prior to LICENSED PROCESS in the end of 20**, COMPANY shall advance at least **** additional new DISCOVERY CANDIDATES to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studiesFIELD.
(g) Within **** of the EFFECTIVE DATE, COMPANY (or an AFFILIATE or a SUBLICENSEE shall file an IND for a THERAPEUTIC PRODUCT by January 1, 20**.
(hSUBLICENSEE) COMPANY or an AFFILIATE or a SUBLICENSEE shall enroll first subject in a Phase I (or equivalent) trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(i) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase II trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(j) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase III trial for a THERAPEUTIC COMPOUND by January 1, 20**.
(k) COMPANY or an AFFILIATE or a SUBLICENSEE shall make a FIRST COMMERCIAL SALE first commercial sale of THERAPEUTIC a LICENSED PRODUCT by January 1, 20**or LICENSED PROCESS in the FIELD. In the event that THE PARTIES determines that COMPANY (or an AFFILIATE or SUBLICENSEE) has failed fails to fulfill any of its obligations under this SectionSection 1, then THE PARTIES may treat such failure as a breach in accordance with Section 12.3(b). Notwithstanding the foregoing, in the event that COMPANY anticipates a failure to meet an obligation set forth in this Section, COMPANY will promptly advise THE PARTIES in writing, and representatives of each party will meet to review the reasons for anticipated failure (taking into account delays beyond the reasonable control of the COMPANY, including action, inaction or delay by the FDA or any comparable regulatory agency and adverse developments with respect to the safety or efficacy of product candidates) and discuss in good faith a potential revision to the diligence schedule. COMPANY and THE PARTIES will enter into a written amendment to the AGREEMENT with respect to any mutually agreed upon change(s) to the relevant obligation(s).
Appears in 3 contracts
Samples: Exclusive Patent License Agreement (MetaStat, Inc.), Exclusive Patent License Agreement (MetaStat, Inc.), Exclusive Patent License Agreement (MetaStat, Inc.)
Diligence Requirements. COMPANY shall use diligent efforts, or shall cause its AFFILIATES to use diligent efforts, to develop LICENSED PRODUCTS or LICENSED PROCESSES to identify DISCOVERY PRODUCTS and to introduce THERAPEUTIC PRODUCTS into the commercial market; thereafter, COMPANY or its AFFILIATES shall make THERAPEUTIC PRODUCTS reasonably available to the public. Specifically, COMPANY or AFFILIATE shall fulfill the following obligations:
(a) Within **** months after the EFFECTIVE DATE, COMPANY shall furnish THE PARTIES with a written research and development plan describing the major tasks to be achieved in order to bring to develop a SCREENING ASSAY, specifying the number of staff and other resources to be devoted to such commercialization effort.
(b) Within **** days after the end of each calendar year, COMPANY shall furnish M.I.T. with a written report (consistent with Section 5.1(a)) on the progress of its efforts during the immediately preceding calendar year to develop and commercialize DISCOVERY PRODUCTS and THERAPEUTIC PRODUCTS using LICENSED PRODUCTS and/or LICENSED PROCESSES in the SCREENING ASSAY. The report shall also contain a discussion of intended efforts and sales projections for THERAPEUTIC PRODUCTS for the year in which the report is submitted.
(c) For each year following the EFFECTIVE DATE, COMPANY or AFFILIATES or SUBLICENSEES shall expend at least the amounts set forth below on research using LICENSED PRODUCT and/or LICENSED PROCESS in the SCREENING ASSAY. Such amounts may be expended by COMPANY or AFFILIATES or SUBLICENSEES, or by research partners. 2013 $100,000 **** 2014 $600,000 **** 2015 $850,000 **** 2016 $1,000,000 **** and every year thereafter until the initiation of a clinical trial - $2,000,000****
(d) By **** months after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall have a working model of a SCREENING ASSAY using LICENSED PRODUCT and/or LICENSED PROCESS.
(e) By **** years after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall identify a DISCOVERY PRODUCT.
(f) Prior to the end of 20**, COMPANY shall advance at least **** new DISCOVERY PRODUCT to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies. Furthermore, prior to the end of 20**, COMPANY shall advance at least **** additional new DISCOVERY CANDIDATES to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies.
(g) COMPANY or an AFFILIATE or a SUBLICENSEE shall file an IND for a THERAPEUTIC PRODUCT by January 1, 20**.
(h) COMPANY or an AFFILIATE or a SUBLICENSEE shall enroll first subject in a Phase I (or equivalent) trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(i) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase II trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(j) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase III trial for a THERAPEUTIC COMPOUND by January 1, 20**.
(k) COMPANY or an AFFILIATE or a SUBLICENSEE shall make a FIRST COMMERCIAL SALE of THERAPEUTIC PRODUCT by January 1, 20**. In the event that THE PARTIES determines that COMPANY (or an AFFILIATE or SUBLICENSEE) has failed to fulfill any of its obligations under this Section, then THE PARTIES may treat such failure as a breach in accordance with Section 12.3(b). Notwithstanding the foregoing, in the event that COMPANY anticipates a failure to meet an obligation set forth in this Section, COMPANY will promptly advise THE PARTIES in writing, and representatives of each party will meet to review the reasons for anticipated failure (taking into account delays beyond the reasonable control of the COMPANY, including action, inaction or delay by the FDA or any comparable regulatory agency and adverse developments with respect to the safety or efficacy of product candidates) and discuss in good faith a potential revision to the diligence schedule. COMPANY and THE PARTIES will enter into a written amendment to the AGREEMENT with respect to any mutually agreed upon change(s) to the relevant obligation(s).
Appears in 1 contract
Samples: Exclusive Patent License Agreement (MetaStat, Inc.)
Diligence Requirements. COMPANY shall use diligent efforts, or shall cause its AFFILIATES to use diligent efforts, to develop LICENSED PRODUCTS or LICENSED PROCESSES to identify DISCOVERY PRODUCTS and to introduce THERAPEUTIC LICENSED PRODUCTS or LICENSED PROCESSES into the commercial market; thereafter, COMPANY or its AFFILIATES shall make THERAPEUTIC LICENSED PRODUCTS or LICENSED PROCESSES reasonably available to the public. Specifically, COMPANY or AFFILIATE shall fulfill the following obligations:
(a) Within **** months after the EFFECTIVE DATE, COMPANY shall furnish THE PARTIES M.I.T. with a written research and development plan describing the major tasks to be achieved in order to bring to develop market a SCREENING ASSAYLICENSED PRODUCT or a LICENSED PROCESS, specifying the number of staff and other resources to be devoted to such commercialization effort.
(b) Within **** sixty (60) days after the end of each calendar year, COMPANY shall furnish M.I.T. with a written report (consistent with Section 5.1(a)) on the progress of its efforts during the immediately preceding calendar year to develop and commercialize DISCOVERY PRODUCTS and THERAPEUTIC PRODUCTS using LICENSED PRODUCTS and/or or LICENSED PROCESSES in the SCREENING ASSAYPROCESSES. The report shall also contain a discussion of intended efforts and sales projections for THERAPEUTIC PRODUCTS for the year in which the report is submitted.
(c) For each year following the EFFECTIVE DATECOMPANY shall develop a working model on or before , COMPANY 200 , and permit an in-plant inspection by M.I.T. on or AFFILIATES or SUBLICENSEES shall expend before , 200 , and thereafter permit in-plant inspections by M.I.T. at regular intervals with at least the amounts set forth below on research using LICENSED PRODUCT and/or LICENSED PROCESS in the SCREENING ASSAY. Such amounts may be expended by COMPANY or AFFILIATES or SUBLICENSEES, or by research partners. 2013 $100,000 2014 $600,000 2015 $850,000 2016 $1,000,000 and every year thereafter until the initiation of a clinical trial - $2,000,000( ) months between each such inspection.
(d) By **** months after the EFFECTIVE DATE, COMPANY shall raise at least Dollars (or an AFFILIATE or SUBLICENSEE$ ) shall have a working model of a SCREENING ASSAY using LICENSED PRODUCT and/or LICENSED PROCESS.by
(e) By **** years after In the EFFECTIVE DATEaggregate, COMPANY shall raise at least Dollars (or an AFFILIATE or SUBLICENSEE$ ) shall identify a DISCOVERY PRODUCTby , 200 from the sale of Company's equity securities for its own account.
(f) Prior to the end of 20**, COMPANY shall advance at least **** new DISCOVERY fund no less than Dollars ($ ) of research toward the development of LICENSED PRODUCTS and/or LICENSED PROCESSES in each calendar year (pro-rated for partial years) beginning in 200 and ending with the first commercial sale of a LICENSED PRODUCT to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support or a first commercial performance of an Investigational New Drug application (“IND”) (or equivalent) for human studies. Furthermore, prior to the end of 20**, COMPANY shall advance at least **** additional new DISCOVERY CANDIDATES to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studiesa LICENSED PROCESS.
(g) COMPANY shall make a first commercial sale of a LICENSED PRODUCT and/or a first commercial performance of a LICENSED PROCESS on or an AFFILIATE or a SUBLICENSEE shall file an IND for a THERAPEUTIC PRODUCT by January 1before , 20**200 .
(h) COMPANY or an AFFILIATE or a SUBLICENSEE shall enroll first subject in a Phase I (or equivalent) trial for a THERAPEUTIC PRODUCT by January 1, 20**make NET SALES according to the following schedule: $ ; $ ; and each year thereafter $ .
(i) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase II trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(j) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase III trial for a THERAPEUTIC COMPOUND by January 1, 20**.
(k) COMPANY or an AFFILIATE or a SUBLICENSEE shall make a FIRST COMMERCIAL SALE sell the following numbers of THERAPEUTIC PRODUCT by January 1, 20**LICENSED PRODUCTS according to the following schedule: 200 units; 200 units; 200 and each year thereafter units. In the event that THE PARTIES M.I.T. determines that COMPANY (or an AFFILIATE or SUBLICENSEEAFFILIATE) has failed to fulfill any of its obligations under this SectionSection 3.1, then THE PARTIES M.I.T. may treat such failure as a material breach in accordance with Section 12.3(b). Notwithstanding the foregoing, in the event that COMPANY anticipates a failure to meet an obligation set forth in this Section, COMPANY will promptly advise THE PARTIES in writing, and representatives of each party will meet to review the reasons for anticipated failure (taking into account delays beyond the reasonable control of the COMPANY, including action, inaction or delay by the FDA or any comparable regulatory agency and adverse developments with respect to the safety or efficacy of product candidates) and discuss in good faith a potential revision to the diligence schedule. COMPANY and THE PARTIES will enter into a written amendment to the AGREEMENT with respect to any mutually agreed upon change(s) to the relevant obligation(s).
Appears in 1 contract
Samples: Exclusive Patent License Agreement
Diligence Requirements. COMPANY shall use diligent efforts, or shall cause its AFFILIATES to use diligent efforts, to develop LICENSED PRODUCTS or LICENSED PROCESSES to identify DISCOVERY PRODUCTS and to introduce THERAPEUTIC LICENSED PRODUCTS or LICENSED PROCESSES into the commercial market; thereafter, COMPANY or its AFFILIATES shall make THERAPEUTIC LICENSED PRODUCTS or LICENSED PROCESSES reasonably available to the public. Specifically, COMPANY or AFFILIATE shall fulfill the following obligations:
(a) Within **** months after the EFFECTIVE DATE, COMPANY shall furnish THE PARTIES with a written research and development plan describing the major tasks to be achieved in order to bring to develop market a SCREENING ASSAYLICENSED PRODUCT or a LICENSED PROCESS in the FIELD, specifying the number of staff and other resources to be devoted to such commercialization effort.
(b) Within **** days after the end of each calendar year, COMPANY shall furnish M.I.T. THE PARTIES with a written report (consistent with Section 5.1(a)) on the progress of its efforts during the immediately preceding calendar year to develop and commercialize DISCOVERY PRODUCTS and THERAPEUTIC PRODUCTS using LICENSED PRODUCTS and/or or LICENSED PROCESSES in the SCREENING ASSAYFIELD. The report shall also contain a discussion of intended efforts and sales projections for THERAPEUTIC PRODUCTS for the year in which the report is submitted.
(c) For each year following the EFFECTIVE DATEDATE until a first commercial sale of a LICENSED PRODUCT in the FIELD, COMPANY or AFFILIATES or SUBLICENSEES shall expend at least the amounts set forth below on research using toward the development of LICENSED PRODUCTS in each calendar year and ending with the first commercial sale of a LICENSED PRODUCT and/or LICENSED PROCESS in the SCREENING ASSAYFIELD. Such amounts may be expended by COMPANY or AFFILIATES or SUBLICENSEES, or by research partners. 2013 $100,000 **** 2014 $600,000 **** 2015 $850,000 **** 2016 $1,000,000 **** and every year thereafter until the initiation of a clinical trial - $2,000,000****
(d) By Within **** months after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall have initiate studies using human patient-derived samples for the purposes of discovering a working model of a SCREENING ASSAY using LICENSED PRODUCT and/or or LICENSED PROCESS in the FIELD.
(e) Within **** after the EFFECTIVE DATE, COMPANY (or an AFFILIATE) shall identify an IDENTIFIED PRODUCT to develop for use in conjunction with a LICENSED PRODUCT or LICENSED PROCESS.
(ef) By Within **** years after of the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall identify a DISCOVERY PRODUCT.
(f) Prior to the end of 20**, COMPANY shall advance at least **** new DISCOVERY PRODUCT to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology initiate clinical studies in support of an Investigational New Drug application (“IND”) (obtaining regulatory approval of a LICENSED PRODUCT or equivalent) for human studies. Furthermore, prior to LICENSED PROCESS in the end of 20**, COMPANY shall advance at least **** additional new DISCOVERY CANDIDATES to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studiesFIELD.
(g) Within **** of the EFFECTIVE DATE, COMPANY (or an AFFILIATE or a SUBLICENSEE shall file an IND for a THERAPEUTIC PRODUCT by January 1, 20**.
(hSUBLICENSEE) COMPANY or an AFFILIATE or a SUBLICENSEE shall enroll first subject in a Phase I (or equivalent) trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(i) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase II trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(j) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase III trial for a THERAPEUTIC COMPOUND by January 1, 20**.
(k) COMPANY or an AFFILIATE or a SUBLICENSEE shall make a FIRST COMMERCIAL SALE first commercial sale of THERAPEUTIC a LICENSED PRODUCT by January 1, 20**or LICENSED PROCESS in the FIELD. In the event that THE PARTIES determines that COMPANY (or an AFFILIATE or SUBLICENSEE) has failed fails to fulfill any of its obligations under this SectionSection 1, then THE PARTIES may treat such failure as a breach in accordance with Section 12.3(b). Notwithstanding the foregoing, in the event that COMPANY anticipates a failure to meet an obligation set forth in this Section, COMPANY will promptly advise THE PARTIES in writing, and representatives of each party will meet to review the reasons for anticipated failure (taking into account delays beyond the reasonable control of the COMPANY, including action, inaction or delay by the FDA or any comparable regulatory agency and adverse developments with respect to the safety or efficacy of product candidates) and discuss in good faith a potential revision to the diligence schedule. COMPANY and THE PARTIES will enter into a written amendment to the AGREEMENT with respect to any mutually agreed upon change(s) to the relevant obligation(s).
Appears in 1 contract
Samples: Exclusive Patent License Agreement (MetaStat, Inc.)
Diligence Requirements. COMPANY shall use diligent efforts, or shall cause its AFFILIATES to use diligent efforts, to develop LICENSED PRODUCTS or LICENSED PROCESSES to identify DISCOVERY PRODUCTS and to introduce THERAPEUTIC LICENSED PRODUCTS or LICENSED PROCESSES into the commercial market; thereafter, COMPANY or its AFFILIATES shall make THERAPEUTIC LICENSED PRODUCTS or LICENSED PROCESSES reasonably available to the public. Specifically, COMPANY or AFFILIATE shall fulfill the following obligations:
(a) Within **** _____ months after the EFFECTIVE DATE, COMPANY shall furnish THE PARTIES WSU with a written research and development plan describing the major tasks to be achieved in order to bring to develop market a SCREENING ASSAYLICENSED PRODUCT or a LICENSED PROCESS, specifying the number of staff and other resources to be devoted to such commercialization effort.. An example is provided in Appendix C.
(b) Within **** sixty (60) days after the end of each calendar year, COMPANY shall furnish M.I.T. WSU with a written report (consistent with Section 5.1(a)) on the progress of its efforts during the immediately preceding calendar year to develop and commercialize DISCOVERY PRODUCTS and THERAPEUTIC PRODUCTS using LICENSED PRODUCTS and/or or LICENSED PROCESSES in the SCREENING ASSAYPROCESSES. The report shall also contain a discussion of intended efforts and sales projections for THERAPEUTIC PRODUCTS for the year in which the report is submitted.. An example is provided in Appendix C.
(c) For each year following the EFFECTIVE DATECOMPANY shall develop a working model on or before __________, COMPANY 201___, and permit an in-plant inspection by WSU on or AFFILIATES or SUBLICENSEES shall expend before __________, 201___, and thereafter permit in-plant inspections by WSU at regular intervals with at least the amounts set forth below on research using LICENSED PRODUCT and/or LICENSED PROCESS in the SCREENING ASSAY. Such amounts may be expended by COMPANY or AFFILIATES or SUBLICENSEES, or by research partners. 2013 $100,000 2014 $600,000 2015 $850,000 2016 $1,000,000 and every year thereafter until the initiation of a clinical trial - $2,000,000______ ( ) months between each such inspection.
(d) By **** months after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall have make a working model first commercial sale of a SCREENING ASSAY using LICENSED PRODUCT and/or a first commercial performance of a LICENSED PROCESSPROCESS on or before ________, 201___.
(e) By **** years after COMPANY shall make NET SALES according to the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall identify a DISCOVERY PRODUCTfollowing schedule: _____ $_________; _____ $_________; _____ and each year thereafter $_________.
(f) Prior COMPANY shall sell the following numbers of LICENSED PRODUCTS according to the end of 20**, COMPANY shall advance at least **** new DISCOVERY PRODUCT to Absorption, Distribution, Metabolism following schedule: 200___ _________ units; 200___ _________ units; 200___ and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies. Furthermore, prior to the end of 20**, COMPANY shall advance at least **** additional new DISCOVERY CANDIDATES to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies.
(g) COMPANY or an AFFILIATE or a SUBLICENSEE shall file an IND for a THERAPEUTIC PRODUCT by January 1, 20**.
(h) COMPANY or an AFFILIATE or a SUBLICENSEE shall enroll first subject in a Phase I (or equivalent) trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(i) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase II trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(j) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase III trial for a THERAPEUTIC COMPOUND by January 1, 20**.
(k) COMPANY or an AFFILIATE or a SUBLICENSEE shall make a FIRST COMMERCIAL SALE of THERAPEUTIC PRODUCT by January 1, 20**each year thereafter _________ units. In the event that THE PARTIES WSU determines that COMPANY (or an AFFILIATE or SUBLICENSEEAFFILIATE) has failed to fulfill any of its obligations under this SectionSection 3.1, then THE PARTIES WSU may treat such failure as a material breach in accordance with Section 12.3(b). Notwithstanding the foregoing, in the event that COMPANY anticipates a failure to meet an obligation set forth in this Section, COMPANY will promptly advise THE PARTIES in writing, and representatives of each party will meet to review the reasons for anticipated failure (taking into account delays beyond the reasonable control of the COMPANY, including action, inaction or delay by the FDA or any comparable regulatory agency and adverse developments with respect to the safety or efficacy of product candidates) and discuss in good faith a potential revision to the diligence schedule. COMPANY and THE PARTIES will enter into a written amendment to the AGREEMENT with respect to any mutually agreed upon change(s) to the relevant obligation(s).
Appears in 1 contract
Samples: Exclusive Patent License Agreement
Diligence Requirements. COMPANY shall will use diligent commercially reasonable efforts, or shall cause its AFFILIATES to use diligent commercially reasonable efforts, to develop one or more LICENSED PRODUCTS or LICENSED PROCESSES to identify DISCOVERY PRODUCTS and to introduce THERAPEUTIC LICENSED PRODUCTS into the commercial market; thereafter, if the LICENSED PRODUCT is approved for commercialization in a market (including without limitation receipt of any necessary pricing and reimbursement authorizations), COMPANY or its AFFILIATES shall make THERAPEUTIC LICENSED PRODUCTS reasonably available to the publicpublic in such market. Specifically, COMPANY or AFFILIATE shall fulfill the following obligations:
(a) Within [**** months ] after the EFFECTIVE DATE, COMPANY shall furnish THE PARTIES M.I.T. with a written research and development plan describing the major tasks to be achieved in order to bring to develop market a SCREENING ASSAYLICENSED PRODUCT, specifying the number of staff and other resources to be devoted to such commercialization effort.
(b) Within [**** days ] after the end of each calendar year, COMPANY shall furnish M.I.T. with a written report (consistent with Section 5.1(a)) on the progress of its efforts during the immediately preceding calendar year to develop and commercialize DISCOVERY LICENSED PRODUCTS. Such report will include the number of DEVELOPMENT CANDIDATES being developed by COMPANY, by its AFFILIATES and by its SUBLICENSEES and a description of the LIPID PRODUCTS and THERAPEUTIC PRODUCTS using LICENSED PRODUCTS and/or LICENSED PROCESSES in the SCREENING ASSAYuse for those DEVELOPMENT CANDIDATES. The report shall also contain a discussion of intended efforts and sales projections for THERAPEUTIC PRODUCTS projections, if applicable, for the year in which the report is submitted.
(c) For each year following the EFFECTIVE DATE, COMPANY or AFFILIATES or SUBLICENSEES (and/or an AFFILIATE) shall expend at least the amounts set forth below (not including funding under the RESEARCH AGREEMENT) on research using and development of LICENSED PRODUCT and/or PRODUCTS in each calendar year (pro-rated for partial years) beginning in 2013 and ending with the FIRST COMMERCIAL SALE of a LICENSED PROCESS in the SCREENING ASSAY. Such amounts may be expended by COMPANY or AFFILIATES or SUBLICENSEES, or by research partnersPRODUCT. 2013 $100,000 [ **] 2014 $600,000 [ **] 2015 $850,000 [ **] 2016 $1,000,000 and every year thereafter until the initiation of a clinical trial - $2,000,000
(d) By [ **** months after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall have a working model of a SCREENING ASSAY using LICENSED PRODUCT and/or LICENSED PROCESS.
(e) By **** years after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall identify a DISCOVERY PRODUCT.
(f) Prior to the end of 20**, COMPANY shall advance at least **** new DISCOVERY PRODUCT to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies. Furthermore, prior to the end of 20**, COMPANY shall advance at least **** additional new DISCOVERY CANDIDATES to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies.
(g) COMPANY or an AFFILIATE or a SUBLICENSEE shall file an IND for a THERAPEUTIC PRODUCT by January 1, 20**.
(h) COMPANY or an AFFILIATE or a SUBLICENSEE shall enroll first subject in a Phase I (or equivalent) trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(i) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase II trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(j) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase III trial for a THERAPEUTIC COMPOUND by January 1, 20**.
(k) COMPANY or an AFFILIATE or a SUBLICENSEE shall make a FIRST COMMERCIAL SALE of THERAPEUTIC PRODUCT by January 1, 20**. In the event that THE PARTIES determines that COMPANY (or an AFFILIATE or SUBLICENSEE) has failed to fulfill any of its obligations under this Section, then THE PARTIES may treat such failure as a breach in accordance with Section 12.3(b). Notwithstanding the foregoing, in the event that COMPANY anticipates a failure to meet an obligation set forth in this Section, COMPANY will promptly advise THE PARTIES in writing, and representatives of each party will meet to review the reasons for anticipated failure (taking into account delays beyond the reasonable control of the COMPANY, including action, inaction or delay by the FDA or any comparable regulatory agency and adverse developments with respect to the safety or efficacy of product candidates) and discuss in good faith a potential revision to the diligence schedule. COMPANY and THE PARTIES will enter into a written amendment to the AGREEMENT with respect to any mutually agreed upon change(s) to the relevant obligation(s).]
Appears in 1 contract
Samples: Exclusive Patent License Agreement (Translate Bio, Inc.)
Diligence Requirements. COMPANY shall use diligent efforts, or shall cause its AFFILIATES to use diligent efforts, to develop LICENSED PRODUCTS or LICENSED PROCESSES to identify DISCOVERY PRODUCTS and to introduce THERAPEUTIC LICENSED PRODUCTS or LICENSED PROCESSES into the commercial market; thereafter, COMPANY or its AFFILIATES shall make THERAPEUTIC LICENSED PRODUCTS or LICENSED PROCESSES reasonably available to the public. Specifically, COMPANY or AFFILIATE shall fulfill the following obligations:
(a) Within **** months after the EFFECTIVE DATE, COMPANY shall furnish THE PARTIES M.I.T. with a written research and development plan describing the major tasks to be achieved in order to bring to develop market a SCREENING ASSAYLICENSED PRODUCT or a LICENSED PROCESS, specifying the number of staff and other resources to be devoted to such commercialization effort.
(b) Within **** sixty (60) days after the end of each calendar year, COMPANY shall furnish M.I.T. with a written report (consistent with Section 5.1(a)) on the progress of its efforts during the immediately preceding calendar year to develop and commercialize DISCOVERY PRODUCTS and THERAPEUTIC PRODUCTS using LICENSED PRODUCTS and/or or LICENSED PROCESSES in the SCREENING ASSAYPROCESSES. The report shall also contain a discussion of intended efforts and sales projections for THERAPEUTIC PRODUCTS for the year in which the report is submitted.
(c) For each year following the EFFECTIVE DATECOMPANY shall develop a working model on or before , COMPANY 200 , and permit an in-plant inspection by M.I.T. on or AFFILIATES or SUBLICENSEES shall expend before , 200 , and thereafter permit in-plant inspections by M.I.T. at regular intervals with at least the amounts set forth below on research using LICENSED PRODUCT and/or LICENSED PROCESS in the SCREENING ASSAY. Such amounts may be expended by COMPANY or AFFILIATES or SUBLICENSEES, or by research partners. 2013 $100,000 2014 $600,000 2015 $850,000 2016 $1,000,000 and every year thereafter until the initiation of a clinical trial - $2,000,000( ) months between each such inspection.
(d) By **** months after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall have make a working model first commercial sale of a SCREENING ASSAY using LICENSED PRODUCT and/or a first commercial performance of a LICENSED PROCESSPROCESS on or before , 200 .
(e) By **** years after COMPANY shall make NET SALES according to the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall identify a DISCOVERY PRODUCTfollowing schedule: $ ; $ ; and each year thereafter $ .
(f) Prior COMPANY shall sell the following numbers of LICENSED PRODUCTS according to the end of 20**, COMPANY shall advance at least **** new DISCOVERY PRODUCT to Absorption, Distribution, Metabolism following schedule: 200 units; 200 units; 200 and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies. Furthermore, prior to the end of 20**, COMPANY shall advance at least **** additional new DISCOVERY CANDIDATES to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies.
(g) COMPANY or an AFFILIATE or a SUBLICENSEE shall file an IND for a THERAPEUTIC PRODUCT by January 1, 20**.
(h) COMPANY or an AFFILIATE or a SUBLICENSEE shall enroll first subject in a Phase I (or equivalent) trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(i) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase II trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(j) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase III trial for a THERAPEUTIC COMPOUND by January 1, 20**.
(k) COMPANY or an AFFILIATE or a SUBLICENSEE shall make a FIRST COMMERCIAL SALE of THERAPEUTIC PRODUCT by January 1, 20**each year thereafter units. In the event that THE PARTIES M.I.T. determines that COMPANY (or an AFFILIATE or SUBLICENSEEAFFILIATE) has failed to fulfill any of its obligations under this SectionSection 3.1, then THE PARTIES M.I.T. may treat such failure as a material breach in accordance with Section 12.3(b). Notwithstanding the foregoing, in the event that COMPANY anticipates a failure to meet an obligation set forth in this Section, COMPANY will promptly advise THE PARTIES in writing, and representatives of each party will meet to review the reasons for anticipated failure (taking into account delays beyond the reasonable control of the COMPANY, including action, inaction or delay by the FDA or any comparable regulatory agency and adverse developments with respect to the safety or efficacy of product candidates) and discuss in good faith a potential revision to the diligence schedule. COMPANY and THE PARTIES will enter into a written amendment to the AGREEMENT with respect to any mutually agreed upon change(s) to the relevant obligation(s).
Appears in 1 contract
Samples: Exclusive Patent License Agreement
Diligence Requirements. COMPANY shall use diligent efforts, or efforts and shall cause its AFFILIATES to use diligent efforts, to develop LICENSED PRODUCTS or LICENSED PROCESSES to identify DISCOVERY PRODUCTS and to introduce THERAPEUTIC LICENSED PRODUCTS or LICENSED PROCESSES into the commercial market; thereafter, COMPANY or its AFFILIATES shall make THERAPEUTIC LICENSED PRODUCTS or LICENSED PROCESSES reasonably available to the public. Specifically, COMPANY or AFFILIATE shall fulfill the following obligations:
(a) Within **** months after the EFFECTIVE DATE, COMPANY shall furnish THE PARTIES M.I.T. with a written research and development plan describing the major tasks to be achieved in order to bring to develop market a SCREENING ASSAYLICENSED PRODUCT or a LICENSED PROCESS, specifying the number of staff and other resources to be devoted to such commercialization effort.
(b) Within **** sixty (60) days after the end of each calendar year, COMPANY shall furnish M.I.T. with a written report (consistent with Section 5.1(a)) on the progress of its efforts during the immediately preceding calendar year to develop and commercialize DISCOVERY PRODUCTS and THERAPEUTIC PRODUCTS using LICENSED PRODUCTS and/or or LICENSED PROCESSES in the SCREENING ASSAYPROCESSES. The report shall also contain a discussion of intended efforts and sales projections for THERAPEUTIC PRODUCTS for the year in which the report is submitted.
(c) For each year following the EFFECTIVE DATECOMPANY shall develop a working model on or before , COMPANY 200 , and permit an in-plant inspection by M.I.T. on or AFFILIATES or SUBLICENSEES shall expend before , 200 , and thereafter permit in-plant inspections by M.I.T. at regular intervals with at least the amounts set forth below on research using LICENSED PRODUCT and/or LICENSED PROCESS in the SCREENING ASSAY. Such amounts may be expended by COMPANY or AFFILIATES or SUBLICENSEES, or by research partners. 2013 $100,000 2014 $600,000 2015 $850,000 2016 $1,000,000 and every year thereafter until the initiation of a clinical trial - $2,000,000( ) months between each such inspection.
(d) By **** months after the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall have make a working model first commercial sale of a SCREENING ASSAY using LICENSED PRODUCT and/or a first commercial performance of a LICENSED PROCESSPROCESS on or before , 200 .
(e) By **** years after COMPANY shall make NET SALES according to the EFFECTIVE DATE, COMPANY (or an AFFILIATE or SUBLICENSEE) shall identify a DISCOVERY PRODUCTfollowing schedule: $ ; $ ; and each year thereafter $ .
(f) Prior COMPANY shall sell the following numbers of LICENSED PRODUCTS according to the end of 20**, COMPANY shall advance at least **** new DISCOVERY PRODUCT to Absorption, Distribution, Metabolism following schedule: 200 units; 200 units; 200 and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies. Furthermore, prior to the end of 20**, COMPANY shall advance at least **** additional new DISCOVERY CANDIDATES to Absorption, Distribution, Metabolism and Excretion (“ADME”) and toxicology studies in support of an Investigational New Drug application (“IND”) (or equivalent) for human studies.
(g) COMPANY or an AFFILIATE or a SUBLICENSEE shall file an IND for a THERAPEUTIC PRODUCT by January 1, 20**.
(h) COMPANY or an AFFILIATE or a SUBLICENSEE shall enroll first subject in a Phase I (or equivalent) trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(i) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase II trial for a THERAPEUTIC PRODUCT by January 1, 20**.
(j) COMPANY or an AFFILIATE or a SUBLICENSEE shall commence a Phase III trial for a THERAPEUTIC COMPOUND by January 1, 20**.
(k) COMPANY or an AFFILIATE or a SUBLICENSEE shall make a FIRST COMMERCIAL SALE of THERAPEUTIC PRODUCT by January 1, 20**each year thereafter units. In the event that THE PARTIES M.I.T. determines that COMPANY (or an AFFILIATE or SUBLICENSEEAFFILIATE) has failed to fulfill any of its obligations under this SectionSection 3.1, then THE PARTIES M.I.T. may treat such failure as a material breach in accordance with Section 12.3(b). Notwithstanding the foregoing, in the event that COMPANY anticipates a failure to meet an obligation set forth in this Section, COMPANY will promptly advise THE PARTIES in writing, and representatives of each party will meet to review the reasons for anticipated failure (taking into account delays beyond the reasonable control of the COMPANY, including action, inaction or delay by the FDA or any comparable regulatory agency and adverse developments with respect to the safety or efficacy of product candidates) and discuss in good faith a potential revision to the diligence schedule. COMPANY and THE PARTIES will enter into a written amendment to the AGREEMENT with respect to any mutually agreed upon change(s) to the relevant obligation(s).
Appears in 1 contract