Diligence Requirements. Company shall use diligent efforts or shall cause its Affiliates or Sublicensees to use diligent efforts to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates or Sublicensees shall fulfill the following obligations: (a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products. (b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year. (c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall: (i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”); (ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product; (iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.; and (iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement. (d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000). (e) In addition to the obligations set forth above, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees at the Medical School) an aggregate of not less than {***} per calendar year for the development of Combination Product and/or Licensed Product commencing with the year 2004. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this Agreement.
Appears in 4 contracts
Samples: Non Exclusive License Agreement (Rxi Pharmaceuticals Corp), Non Exclusive License Agreement (Rxi Pharmaceuticals Corp), Non Exclusive License Agreement (Cytrx Corp)
Diligence Requirements. Company shall use diligent efforts or shall cause its Affiliates or Sublicensees to use diligent efforts to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter. Thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates or Sublicensees shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective DateOn or before execution of this Agreement, Company shall furnish Medical School University with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty [*] days after each anniversary of the Effective Date for the first [*] years, Company shall furnish University with a copy of the Company’s business plan.
(60c) Within [*] days after each anniversary of the Effective Date, Company shall furnish Medical School University with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development effortsdevelopment, efforts to obtain regulatory approval, marketing effortsmarketing, and sales figures. The report Company shall also contain include in the report a discussion of its intended efforts and sales projections for the current year.
(cd) On or before [*], Company shall endeavor have in place a qualified management team that is acceptable to obtain all necessary governmental approvals for the manufacture, use and sale Company’s board of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreementdirectors.
(de) Within eighteen (18) [*] months after the Effective Date, Company shall successfully undertake a public or private offering obtain financing from qualified investors of raising ten million dollars at least [*] ($10,000,000the “Initial Financing).
(ef) In addition Within [*] months after the Effective Date, Company shall notify the University in writing whether company is interested in retaining rights to the obligations set forth abovePatent Rights in the following fields: pharmaceutical, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees at the Medical School) an aggregate of not less than {***} per calendar year for the development of Combination Product and/or Licensed Product commencing with the year 2004. Company shall have the responsibility to finance its obligations in this Section 3.1nutriceutical, agricultural, and diagnostic applications.
(i) Within [*] months after the Medical School shall provide Effective Date, if the Company is not engaged in reasonable cooperation commercial efforts to develop Licensed Products within those fields, the University may notice the Company of its intention to terminate this Agreement as it pertains to those fields.
(ii) Within [*] days after the University’s notice pursuant to Subsection 3.1(3)(i), if the Company is not engaged in reasonable commercial efforts to develop Licensed Products within any field or fields noticed by the University, then the University may immediately terminate this regardAgreement as it pertains to those fields, and those fields are no longer part of the Field of this Agreement.
(g) Within [*] years after the Effective Date, if Company has not made the first sale of a cosmetic Licensed Product, the University may notice the Company of its intention to terminate this Agreement as it pertains to the cosmetic field. In the event that Medical School If University determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School University shall furnish Company with written notice of such the determination. Within sixty (60) [*] days after receipt of such the notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School University a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the rightUniversity may, immediately upon written notice to Company, terminate this Agreement or convert the exclusive license into a non-exclusive license. If the reason for non-fulfillment of its obligations is lack of Company funds, Company has [*] months to fulfill the obligation, and the University may not exercise its right to terminate this AgreementAgreement or convert the exclusive license to non-exclusive until the expiration of that [*] months.
Appears in 3 contracts
Samples: Exclusive License Agreement (Anterios Inc), Exclusive License Agreement (Anterios Inc), Exclusive License Agreement (Anterios Inc)
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or and Sublicensees to use diligent efforts efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates Affiliate or Sublicensees Sublicensee shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth above, Company or and/or its Affiliates or Sublicensees sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees Sublicensee at the Medical School) an aggregate of not less than {***} per calendar year for the development of Combination Product and/or Licensed Product commencing with the year 2004. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this AgreementAgreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. The Medical School may not unreasonably withhold acceptance of Company’s revised diligence obligations.
Appears in 3 contracts
Samples: Exclusive License Agreement (Cytrx Corp), Exclusive License Agreement (Rxi Pharmaceuticals Corp), Exclusive License Agreement (Rxi Pharmaceuticals Corp)
Diligence Requirements. Company shall use diligent efforts or shall cause its Affiliates or Sublicensees to use diligent efforts to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates or Sublicensees shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth above, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees at the Medical School) an aggregate of not less than {[* * ***} ] per calendar year for the development of Combination Product and/or Licensed Product commencing with the year 2004. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this Agreement.
Appears in 2 contracts
Samples: Non Exclusive License Agreement (RXi Pharmaceuticals Corp), Non Exclusive License Agreement (RXi Pharmaceuticals Corp)
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or and Sublicensees to use diligent efforts efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates Affiliate or Sublicensees Sublicensee shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.U.S. ; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth aboveWithin three months of Effective Date, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored commit to fund basic research by Company or its Affiliates or Sublicensees in the laboratory of Dx. Xxxxxxx Xxxxxxx at the Medical School) an aggregate amount of not less than at least {***} per calendar in direct Medical School costs in the first year, {***} in direct Medical School costs in the second year, and {***} in direct Medical School costs in the third year towards in support of licensed Patent Rights and/or related technology. In addition to direct Medical School costs, Company sponsored research is subject to indirect cost rates, currently fifty percent (50%) for basic research. Company shall enter into a formal sponsored research agreement with Medical School in a separate agreement. During the development term of Combination Product and/or Licensed Product commencing with any agreement covering funding described in this Section 3.1(e), if a lower indirect cost rate is afforded to any other industrial sponsor by the year 2004Office of Technology Management of the Medical School or if the federal indirect cost rate is reduced, the indirect cost rate charged to the Company shall prospectively be reduced to that lower rate. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this AgreementAgreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. The Medical School may not unreasonably withhold acceptance of Company’s revised diligence obligations.
Appears in 2 contracts
Samples: Exclusive License Agreement (Rxi Pharmaceuticals Corp), Exclusive License Agreement (Rxi Pharmaceuticals Corp)
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or and Sublicensees to use diligent efforts efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates Affiliate or Sublicensees Sublicensee shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth above, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees at the Medical School) an aggregate of not less than {***} per calendar year for the development of Combination Product and/or Licensed Product commencing with the year 2004. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this AgreementAgreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. The Medical School may not unreasonably withhold acceptance of Company’s revised diligence obligations.
Appears in 2 contracts
Samples: Exclusive License Agreement (Cytrx Corp), Exclusive License Agreement (Cytrx Corp)
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or and Sublicensees to use diligent efforts efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates Affiliate or Sublicensees Sublicensee shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.U.S. ; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth aboveWithin three months of Effective Date, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored commit to fund basic research by Company or its Affiliates or Sublicensees in the laboratory of Xx. Xxxxxxx Xxxxxxx at the Medical School) an aggregate amount of not less than at least {***} per calendar in direct Medical School costs in the first year, {***} in direct Medical School costs in the second year, and {***} in direct Medical School costs in the third year towards in support of licensed Patent Rights and/or related technology. In addition to direct Medical School costs, Company sponsored research is subject to indirect cost rates, currently fifty percent (50%) for basic research. Company shall enter into a formal sponsored research agreement with Medical School in a separate agreement. During the development term of Combination Product and/or Licensed Product commencing with any agreement covering funding described in this Section 3.1(e), if a lower indirect cost rate is afforded to any other industrial sponsor by the year 2004Office of Technology Management of the Medical School or if the federal indirect cost rate is reduced, the indirect cost rate charged to the Company shall prospectively be reduced to that lower rate. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this AgreementAgreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. The Medical School may not unreasonably withhold acceptance of Company’s revised diligence obligations.
Appears in 2 contracts
Samples: Exclusive License Agreement (Cytrx Corp), Exclusive License Agreement (Cytrx Corp)
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or and Sublicensees to use diligent efforts efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates Affiliate or Sublicensees Sublicensee shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.U.S. ; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth above, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees at the Medical School) an aggregate of not less than {***} per calendar year for the development of Combination Product and/or Licensed Product commencing with the year 2004. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this AgreementAgreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. The Medical School may not unreasonably withhold acceptance of Company’s revised diligence obligations.
Appears in 2 contracts
Samples: Exclusive License Agreement (Cytrx Corp), Exclusive License Agreement (Cytrx Corp)
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or and Sublicensees to use diligent efforts efforts, to develop Licensed Products and to introduce Licensed Products into the commercial marketmarket place; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates Affiliate or Sublicensees Sublicensee shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after the start of each anniversary calendar year during the term of the Effective Datethis Agreement, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use use, and sale of Combination Product and Licensed Product. Specifically, Company shall:Products.
(id) Within eight seven (8) 7) years after the Effective Date, Company shall file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. United States Food and Drug Administration (“FDA”);.
(iie) Within thirteen ten (1310) years after the Effective Date, Company shall file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;.
(iiif) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, Company shall market at least one Combination Product or Licensed Product in the U.S.; andUnited States.
(ivg) reasonably fill the market demand for any Combination Product or Licensed Product following Following commencement of marketing of such product a Licensed Product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to reasonably fill the obligations set forth above, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees at the Medical School) an aggregate of not less than {***} per calendar year market demand for the development of Combination Product and/or any Licensed Product commencing with the year 2004Product. Company shall have has the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this Agreement. The Medical School may not unreasonably withhold acceptance of Company’s revised diligence obligations.
Appears in 2 contracts
Samples: License Agreement (Rxi Pharmaceuticals Corp), License Agreement (Rxi Pharmaceuticals Corp)
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or Sublicensees to use diligent efforts efforts, to develop Licensed Products or Licensed Services and to introduce Licensed Products or Licensed Services into the commercial market; thereafter. Thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products or Licensed Services reasonably available to the public. Specifically, Company or its Affiliates or Sublicensees shall fulfill the following obligations:
(a) Within ninety six (906) days months after the Effective DateDate of this Agreement, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed ProductsProducts or Licensed Services.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed ProductsProducts or Licensed Services, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use use, and sale of Licensed Products and Combination Product and Products or the performance of Licensed ProductServices. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. United States Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.United States; and
(iv) reasonably Reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such the product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten or otherwise commit at least three million dollars ($10,000,000)3,000,000) to the business of Araios or such other entity, division, or operation of Company devoted to the development and commercialization of Licensed Products in the Field.
(e) In addition to Within three months after the obligations set forth aboveEffective Date, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored commit to fund basic research by Company or its Affiliates or Sublicensees in the laboratory of Dr. Michael Czech at the Medical School) an aggregate amount of not less than at least {***} per calendar in direct Medical School costs in the first year, {***} in direct Medical School costs in the second year, and {***} in direct Medical School costs in the third year towards in support of licensed Patent Rights and/or Related Technology. In addition to direct Medical School costs, Company sponsored research is subject to indirect cost rates, currently fifty percent (50%), for the development of Combination Product and/or Licensed Product commencing with the year 2004basic research. Company shall have enter into a formal sponsored research agreement with Medical School in a separate agreement. During the responsibility term of any agreement covering funding described in this Section 3.1(e), if a lower indirect cost rate is afforded to finance any other industrial sponsor by the Office of Technology Management of the Medical School or if the federal indirect cost rate is reduced, the indirect cost rate charged to the Company shall prospectively be reduced to that lower rate. Company is responsible for financing its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to the Company in this regard. In the event that If Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such the determination. Within sixty (60) days after receipt of such the notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the rightmay, immediately upon written notice to Company, to terminate this AgreementAgreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. The Medical School may not unreasonably withhold acceptance of Company’s revised diligence obligations.
Appears in 2 contracts
Samples: License Agreement (Rxi Pharmaceuticals Corp), License Agreement (Rxi Pharmaceuticals Corp)
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or and Sublicensees to use diligent efforts efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates Affiliate or Sublicensees Sublicensee shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.U.S. ; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth above, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees at the Medical School) an aggregate of not less than {***} per calendar year for the development of Combination Product and/or Licensed Product commencing with the year 2004. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either either
(i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this AgreementAgreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. The Medical School may not unreasonably withhold acceptance of Company’s revised diligence obligations.
Appears in 2 contracts
Samples: Exclusive License Agreement (Rxi Pharmaceuticals Corp), Exclusive License Agreement (Rxi Pharmaceuticals Corp)
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or and Sublicensees to use diligent efforts efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates Affiliate or Sublicensees Sublicensee shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.U.S. ; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth aboveWithin three months of Effective Date, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored commit to fund basic research by Company or its Affiliates or Sublicensees in the laboratory of Xx. Xxxx Xx at the Medical School) an aggregate amount of not less than at least at least {***} per calendar in direct Medical School costs in the first year, {***} in direct Medical School costs in the second year, and {***} in direct Medical School costs in the third year towards in support of licensed Patent Rights and/or related technology. In addition to direct Medical School costs, Company sponsored research is subject to indirect cost rates, currently fifty percent (50%) for basic research. Company shall enter into a formal sponsored research agreement with Medical School in a separate agreement. During the development term of Combination Product and/or Licensed Product commencing with any agreement covering funding described in this Section 3.1(e), if a lower indirect cost rate is afforded to any other industrial sponsor by the year 2004Office of Technology Management of the Medical School or if the federal indirect cost rate is reduced, the indirect cost rate charged to the Company shall prospectively be reduced to that lower rate. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this AgreementAgreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. The Medical School may not unreasonably withhold acceptance of Company’s revised diligence obligations.
Appears in 2 contracts
Samples: Exclusive License Agreement (Cytrx Corp), Exclusive License Agreement (Cytrx Corp)
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or and Sublicensees to use diligent efforts efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates Affiliate or Sublicensees Sublicensee shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.U.S. ; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth aboveWithin three months of Effective Date, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored commit to fund basic research by Company or its Affiliates or Sublicensees in the laboratory of Dr. Michael Czech at the Medical School) an aggregate amount of not less than at least {***} per calendar in direct Medical School costs in the first year, {***} in direct Medical School costs in the second year, and {***} in direct Medical School costs in the third year towards in support of licensed Patent Rights and/or related technology. In addition to direct Medical School costs, Company sponsored research is subject to indirect cost rates, currently fifty percent (50%) for basic research. Company shall enter into a formal sponsored research agreement with Medical School in a separate agreement. During the development term of Combination Product and/or Licensed Product commencing with any agreement covering funding described in this Section 3.1(e), if a lower indirect cost rate is afforded to any other industrial sponsor by the year 2004Office of Technology Management of the Medical School or if the federal indirect cost rate is reduced, the indirect cost rate charged to the Company shall prospectively be reduced to that lower rate. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this AgreementAgreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. The Medical School may not unreasonably withhold acceptance of Company’s revised diligence obligations.
Appears in 2 contracts
Samples: Exclusive License Agreement (Cytrx Corp), Exclusive License Agreement (Cytrx Corp)
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or Sublicensees to use diligent efforts efforts, to develop Licensed Products or Licensed Services and to introduce Licensed Products or Licensed Services into the commercial market; thereafter. Thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products or Licensed Services reasonably available to the public. Specifically, Company or its Affiliates or Sublicensees shall fulfill the following obligations:
(a) Within ninety six (906) days months after the Effective DateDate of this Agreement, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed ProductsProducts or Licensed Services.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed ProductsProducts or Licensed Services, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use use, and sale of Licensed Products and Combination Product and Products or the performance of Licensed ProductServices. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“"IND”") or its equivalent covering at least one Combination Product or Licensed Product with the U.S. United States Food and Drug Administration (“"FDA”");
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“"NDA”") with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.United States; and
(iv) reasonably Reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such the product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten or otherwise commit at least three million dollars ($10,000,000)3,000,000) to the business of Araios or such other entity, division, or operation of Company devoted to the development and commercialization of Licensed Products in the Field.
(e) In addition to Within three months after the obligations set forth aboveEffective Date, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored commit to fund basic research by Company or its Affiliates or Sublicensees in the laboratory of Dr. Michael Czech at the Medical School) an aggregate amount of not less than at least {***} per calendar in direct Medical School costs in the first year, {***} in direct Medical School costs in the second year, and {***} in direct Medical School costs in the third year towards in support of licensed Patent Rights and/or Related Technology. In addition to direct Medical School costs, Company sponsored research is subject to indirect cost rates, currently fifty percent (50%), for the development of Combination Product and/or Licensed Product commencing with the year 2004basic research. Company shall have enter into a formal sponsored research agreement with Medical School in a separate agreement. During the responsibility term of any agreement covering funding described in this Section 3.1(e), if a lower indirect cost rate is afforded to finance any other industrial sponsor by the Office of Technology Management of the Medical School or if the federal indirect cost rate is reduced, the indirect cost rate charged to the Company shall prospectively be reduced to that lower rate. Company is responsible for financing its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to the Company in this regard. In the event that If Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such the determination. Within sixty (60) days after receipt of such the notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the rightmay, immediately upon written notice to Company, to terminate this AgreementAgreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. The Medical School may not unreasonably withhold acceptance of Company's revised diligence obligations.
Appears in 1 contract
Samples: License Agreement (Cytrx Corp)
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or and Sublicensees to use diligent efforts efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates Affiliate or Sublicensees Sublicensee shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth above, Company or and/or its Affiliates or Sublicensees sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees Sublicensee at the Medical School) an aggregate of not less than {***} per calendar year for the development of Combination Product and/or Licensed Product commencing with the year 2004. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, *** The information marked by asterisks on this page has been omitted pursuant to a request for confidential treatment. The omitted information has been filed separately with the Securities and Exchange Commission. immediately upon written notice to Company, to terminate this AgreementAgreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. The Medical School may not unreasonably withhold acceptance of Company’s revised diligence obligations.
Appears in 1 contract
Diligence Requirements. Company shall use diligent efforts efforts, or shall cause its Affiliates or and Sublicensees to use diligent efforts efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates Affiliate or Sublicensees Sublicensee shall fulfill the following obligations:
(a) Within ninety (90) days after the Effective Dateinitiation of the Phase I Trial, Company shall furnish Medical School and ABL with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School and ABL with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“"IND”") or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”)FDA with this requirement to be deemed to have been satisfied upon the filing of the ABL IND;
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“"NDA”") with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.U.S. ; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth above, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees at the Medical School) an aggregate of not less than {***} per calendar year for the development of Combination Product and/or Licensed Product commencing with the year 2004. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School and ABL shall provide reasonable cooperation to Company in this regard. In the event that Medical School or ABL determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School or ABL shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School and ABL a mutually acceptable schedule of revised diligence obligations, failing which Medical School and ABL shall have the right, immediately upon written notice to CompanyCompany and subject to Sections 8.2 and 9, to terminate this AgreementAgreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. Neither Medical School nor ABL may not unreasonably withhold acceptance of Company's revised diligence obligations.
Appears in 1 contract
Diligence Requirements. Company shall use diligent efforts or commercially reasonable efforts, and shall cause its Affiliates or Sublicensees to use diligent efforts commercially reasonable efforts, to develop Licensed Products and to introduce Licensed Products into the commercial market; thereafter. Thereafter, Company or and its Affiliates or Sublicensees shall make Licensed Products reasonably available to the public. Specifically, Company or its Affiliates or Sublicensees shall fulfill the following obligations:
(a) Within ninety sixty (9060) days after of the Effective Datedelivery of the optimized flu DNA vaccine plasmids ready for GMP manufacturing, Company shall furnish Medical School University with a written research and development plan under which Company intends to develop Licensed Products.
(b) Within sixty (60) days after each anniversary of the Effective Datedelivery of the optimized flu DNA vaccine plasmids ready for GMP manufacturing, Company shall furnish Medical School University with a written report on the progress of its commercially reasonable efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, commercially reasonable efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.. The Company shall use its commercially reasonable efforts to achieve the following:
(c) Within two (2) years of the anniversary of the delivery of the optimized flu DNA vaccine plasmids ready for GMP manufacturing, Company shall endeavor to obtain all necessary governmental approvals have filed an IND or equivalent.
(d) Within three (3) years of the anniversary of the delivery of the optimized flu DNA vaccine plasmids ready for the manufacture, use and sale of Combination Product and Licensed Product. SpecificallyGMP manufacturing, Company shall:shall have initiated a Phase I clinical trial.
(ie) Within four (4) years of the anniversary of the delivery of the optimized flu DNA vaccine plasmids ready for GMP manufacturing, Company shall have initiated a Phase II clinical trial.
(f) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA anniversary of the delivery of the optimized flu DNA vaccine plasmids ready for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective DateGMP manufacturing, Company shall successfully undertake have initiated a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth above, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees at the Medical School) an aggregate of not less than {***} per calendar year for the development of Combination Product and/or Licensed Product commencing with the year 2004Phase III clinical trial. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School If University determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School University shall furnish Company with written notice of such the determination. Within sixty (60) days after receipt of such the notice, Company shall either (i) fulfill the relevant obligation or (ii) negotiate with Medical School University a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the rightUniversity may, immediately upon written notice to Company, to terminate this AgreementAgreement or convert the exclusive license into a non-exclusive license and grant additional licenses to third parties to the Patent Rights in the Field.
Appears in 1 contract
Diligence Requirements. Company shall use diligent efforts commercially reasonable efforts, or shall cause its Affiliates or and Sublicensees to use diligent efforts commercially reasonable efforts, to develop Licensed Products Product and to introduce Licensed Products Product into the commercial market; thereafter, Company or its Affiliates or Sublicensees shall make Licensed Products Product reasonably available to the public. Specifically, Company or its Affiliates or Sublicensees shall fulfill agrees to the following obligationsfollowing:
(a) a. Within ninety (90) days after the Effective Date, Company shall furnish Medical School SJCRH with a written research plan under which Company intends to conduct research to evaluate opportunities to exploit Patent Rights (the "Research Plan"). The parties acknowledge that, from time to time, and development depending on outcome of such research, the Research Plan may merit revision, in which case, the parties agree to confer in good faith to negotiate such revision(s) to the Research Plan.
b. No later [*], Company shall furnish SJCRH with a written plan (the "Development Plan") under which Company intends to develop Licensed ProductsProduct. Thereafter, Company may revise the Development Plan to SJCRH's reasonable satisfaction to accommodate uncertainties inherent in the drug development process, including but not limited to, regulatory delay or unexpected regulatory requirements, additional or unexpected scientific or clinical data, and delays in patient recruitment.
(b) c. Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School SJCRH with a brief written report on the progress of its efforts during the prior year to research, develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
(c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
(i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
(ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
(iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S.; and
(iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
(d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
(e) In addition to the obligations set forth above, Company or its Affiliates or Sublicensees shall spend (either directly or through sponsored research by Company or its Affiliates or Sublicensees at the Medical School) an aggregate of not less than {***} per calendar year for the development of Combination Product and/or Licensed Product commencing with the year 2004. Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School SJCRH reasonably determines that Company (Company, or an Affiliate or Sublicensee) , has not fulfilled its material obligations under this Section the Sections 3.1.. (a) or (b), Medical School SJCRH shall furnish Company with written notice of such determination. Within sixty (60) days after Upon Company's receipt of such written notice, Company shall either use good faith efforts to: (i) prove to SJCRH's reasonable satisfaction that Company has fulfilled its obligations under Sections 3.1. (a) or (b); (ii) fulfill the relevant obligation obligation; or (iii) negotiate with SJCRH mutually acceptable revisions to the Research Plan, Development Plan, or Section 3.1. (a) or (b), as applicable. If Company has not complied with (i), (ii) negotiate with Medical School a mutually acceptable schedule or (iii) within ninety (90) days after Company's receipt of revised diligence obligationsSJCRH's written notice, failing which Medical School SJCRH shall have the right, immediately upon written [*] designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission. notice to CompanyCompany and subject to Section 9 of this Agreement, to terminate this AgreementAgreement or to convert Company's license into a non-exclusive license and grant additional licenses under the Patent Rights in the Field. If SJCRH converts Company's license into a non-exclusive license, the amounts payable under Sections 4.2 and 4.3 shall be reduced [*].
Appears in 1 contract
Samples: License Agreement (Zymogenetics Inc)