Common use of Development of Licensed Products Clause in Contracts

Development of Licensed Products. (i) On or before execution of this Agreement, Company shall furnish University with a written business plan under which Company intends as of the Effective Date to develop Licensed Products. University acknowledges that this business plan is a statement of Company’s current intention regarding the development of Licensed Product and that Company’s plans regarding the development of Licensed Products may change. (ii) Within sixty (60) days after the start of each calendar year, beginning on January 1, 2008, Company shall furnish University with a written report on progress during the prior year to develop and commercialize Licensed Products, including without limitation research and development, efforts to obtain regulatory approval, marketing, and sales figures. The Company shall also include in the report a discussion of its intended development and commercialization efforts and sales projections for the current year. (iii) Within five (5) years after the Effective Date, Company, its Affiliate or Sublicensee shall file an IND or its equivalent with the FDA covering at least one (1) Licensed Product. (iv) Within twelve (12) years after the Effective Date, Company, its Affiliate or Sublicensee shall file an NDA or BLA with the FDA covering at least one (1) Licensed Product. (v) Within three (3) months after receiving FDA approval of the NDA or BLA for any Licensed Product, Company, its Affiliate or Sublicensee shall market the approved Licensed Product in the United States. (vi) Company or its partner shall spend at least {***} per calendar year for development of Licensed Products until the earlier of three years after the Effective Date or the commencement of a Phase II clinical trial on a Licensed Product.

Appears in 6 contracts

Samples: Exclusive License Agreement (Rxi Pharmaceuticals Corp), Exclusive License Agreement (Rxi Pharmaceuticals Corp), Exclusive License Agreement (Rxi Pharmaceuticals Corp)

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Development of Licensed Products. (i) On or before execution of this Agreement, Company shall furnish University with a written business plan under which Company intends as of the Effective Date to develop Licensed Products. University acknowledges that this business plan is a statement of Company’s current intention regarding the development of Licensed Product and that Company’s plans regarding the development of Licensed Products may change. (ii) Within sixty (60) days after the start of each calendar year, beginning on January 1, 2008, Company shall furnish University with a written report on progress during the prior year to develop and commercialize Licensed Products, including without limitation research and development, efforts to obtain regulatory approval, marketing, and sales figures. The Company shall also include in the report a discussion of its intended development and commercialization efforts and sales projections for the current year. (iii) Within five (5) years after the Effective Date, Company, its Affiliate or Sublicensee shall file an IND or its equivalent with the FDA covering at least one (1) Licensed Product. (iv) Within twelve thirteen (1213) years after the Effective Date, Company, its Affiliate or Sublicensee shall file an NDA or BLA with the FDA covering at least one (1) Licensed Product. (v) Within three (3) months after receiving FDA approval of the NDA or BLA for any each Licensed Product, Company, its Affiliate or Sublicensee shall market the approved Licensed Product in the United States. (vi) Company or its partner shall spend at least {***} per calendar year for development of Licensed Products until the earlier of three years after the Effective Date or the commencement of a Phase II clinical trial on a Licensed Product. (vii) Within three years after the Effective Date, Company shall enter into a bona fide collaboration or strategic alliance with a third party commercial entity having a market capitalization greater than that of Company, such as, a large pharmaceutical or biotechnology company, for research and development of Licensed Products in a field that includes the Primary Field.

Appears in 3 contracts

Samples: Exclusive License Agreement (Cytrx Corp), Exclusive License Agreement (Rxi Pharmaceuticals Corp), Exclusive License Agreement (Rxi Pharmaceuticals Corp)

Development of Licensed Products. (i) On or before execution of this Agreement, Company shall furnish University with a written business plan under which Company intends as of the Effective Date to develop Licensed Products. University acknowledges that this business plan is a statement of Company’s current intention regarding the development of Licensed Product and that Company’s plans regarding the development of Licensed Products may change. (ii) Within sixty (60) days after the start of each calendar year, beginning on January 1, 2008, Company shall furnish University with a written report on progress during the prior year to develop and commercialize Licensed Products, including without limitation research and development, efforts to obtain regulatory approval, marketing, and sales figures. The Company shall also include in the report a discussion of its intended development and commercialization efforts and sales projections for the current year. (iii) Within five four (54) years after the Effective Date, Company, Company or its Affiliate or Sublicensee shall file an IND or its equivalent with the FDA covering at least one (1) Licensed Product. (iv) Within twelve (12) years after the Effective Date, Company, its Affiliate or Sublicensee shall file an NDA or BLA with the FDA covering at least one (1) Licensed Product. (v) Within three (3) months after receiving FDA approval of the NDA or BLA for any each Licensed Product, Company, Company or its Affiliate or Sublicensee shall market the approved Licensed Product in the United States. (vi) Company or its partner shall spend at least {***} per calendar year for development of Licensed Products until the earlier of three years after the Effective Date or the commencement of a Phase II clinical trial on a Licensed Product.

Appears in 3 contracts

Samples: Non Exclusive License Agreement (Rxi Pharmaceuticals Corp), Non Exclusive License Agreement (Rxi Pharmaceuticals Corp), Non Exclusive License Agreement (Cytrx Corp)

Development of Licensed Products. (i) On or before execution Within [*] days of this Agreementthe Commencement Date, Company shall furnish University with a written business plan under which Company intends as of the Effective Commencement Date to develop Licensed Products. University acknowledges that this business plan is a statement of Company’s current intention regarding the development of Licensed Product and that Company’s plans regarding the development of Licensed Products may change. (ii) Within sixty (60) [*] days after the start of each calendar year, beginning on January 1, 2008, 2014 Company shall furnish University with a written report on progress during the prior year to develop and commercialize Licensed Products, including without limitation research and development, efforts to obtain regulatory approval, marketing, and sales figures. The Company shall also include in the report a discussion of its intended development and commercialization efforts and sales projections for the current year. (iii) Within five (5) years after the Effective DateDuring [*], Company, its Affiliate or Sublicensee shall file an IND commence a Phase I clinical trial or its equivalent covering at least one (1) Licensed Product. (iv) During [*], Company, its Affiliate or Sublicensee shall commence a Phase II clinical trial or its equivalent covering at least one (1) Licensed Product, should such a trial be required by the FDA. (v) During [*], Company, its Affiliate or Sublicensee shall commence a Phase III clinical trial or its equivalent covering at least one (1) Licensed Product. (vi) No later than [*], Company, its Affiliate or Sublicensee shall be ready to file a New Drug Application (“NDA”) or Biologics License Application (“BLA”) with the FDA covering at least one (1) Licensed Product. (ivvii) Within twelve (12) years after the Effective Date, Company, its Affiliate or Sublicensee shall file an NDA or BLA with the FDA covering at least one (1) Licensed Product. (v) Within three (3) [*] months after receiving FDA approval of the NDA or BLA for any Licensed Product, Company, its Affiliate or Sublicensee shall market the approved Licensed Product in the United States. (vi) Company or its partner shall spend at least {***} per calendar year for development of Licensed Products until the earlier of three years after the Effective Date or the commencement of a Phase II clinical trial on a Licensed Product.

Appears in 1 contract

Samples: Exclusive License Agreement (BioLineRx Ltd.)

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Development of Licensed Products. (i) On or before execution Within [*] days of this Agreementthe Commencement Date, Company shall furnish University with a written business plan under which Company intends as of the Effective Commencement Date to develop Licensed Products. University acknowledges that this business plan is a statement of Company’s current intention regarding the development of Licensed Product and that Company’s plans regarding the development of Licensed Products may change. (ii) Within sixty (60) [*] days after the start of each calendar year, beginning on January 1, 2008, 2014 Company shall furnish University with a written report on progress during the prior year to develop and commercialize Licensed Products, including without limitation research and development, efforts to obtain regulatory approval, marketing, and sales figures. The Company shall also include in the report a discussion of its intended development and commercialization efforts and sales projections for the current year. (iii) Within five (5) [*] years after the Effective Commencement Date, Company, its Affiliate or Sublicensee shall commence a Phase I clinical trial or its equivalent covering at least one (1) Licensed Product. (iv) Within [*] years after the Commencement Date, Company, its Affiliate or Sublicensee shall commence a Phase II clinical trial or its equivalent covering at least one (1) Licensed Product. (v) Within [*] years after the Commencement Date, Company, its Affiliate or Sublicensee shall commence a Phase III clinical trial or its equivalent covering at least one (1) Licensed Product. (vi) Within [*] years after the Commencement Date, Company, its Affiliate or Sublicensee shall file an IND a New Drug Application (“NDA”) or its equivalent Biologics License Application (“BLA”) with the FDA covering at least one (1) Licensed Product. (ivvii) Within twelve (12) years after the Effective Date, Company, its Affiliate or Sublicensee shall file an NDA or BLA with the FDA covering at least one (1) Licensed Product. (v) Within three (3) [*] months after receiving FDA approval of the NDA or BLA for any Licensed Product, Company, its Affiliate or Sublicensee shall market the approved Licensed Product in the United States. (vi) Company or its partner shall spend at least {***} per calendar year for development of Licensed Products until the earlier of three years after the Effective Date or the commencement of a Phase II clinical trial on a Licensed Product.

Appears in 1 contract

Samples: Exclusive License Agreement (BioLineRx Ltd.)

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