Common use of Development and Commercialization Program Clause in Contracts

Development and Commercialization Program. 2.1 Commencing on the Effective Date, the parties shall collaborate in the development and commercialization of the Licensed Product in the Licensed Field. The program of activities to be conducted by each of Corixa and ZKC during the term of the Agreement is set forth on Exhibit C (the "Development and Commercialization Program"), which shall be amended on an annual basis by mutual agreement of the parties, effective upon each anniversary of the Effective Date. The Development and Commercialization Program shall include a development plan setting forth the activities currently contemplated by the parties to be performed in developing the Licensed Product, as well as a description of each party's responsibilities in connection with the development and commercialization of the Licensed Product. Anything herein to the contrary notwithstanding, the timelines included in the development plan are non-binding and shall function as guidelines only for the development of Licensed Product and may be modified from time to time by the Development Steering Committee. The parties agree that the end goal of the Development and Commercialization Program shall be the expeditious clinical development and regulatory approval of the Licensed Product as necessary for the import, manufacture, marketing and/or sale thereof in the Territory in the Licensed Field. No material deviation in the subject matter and scope of such Development and Commercialization Program shall be made without the mutual written agreement of both parties. 2.2 On the Effective Date, ZKC agrees to diligently undertake, [*], pre-clinical and clinical development and commercialization of the Licensed Product within the Territory as determined by the Development Steering Committee or Commercialization Steering Committee, as applicable. ZKC shall have the right, subject to the terms and conditions of this Agreement, including, without limitation, Section 3 hereof, to determine the clinical development and commercialization plan for the Licensed Product in the Territory. 2.3 The parties acknowledge and agree that nothing in this Agreement shall restrict in any manner Corixa's ability to conduct clinical trials of any nature either inside or outside of the Licensed Field [*] or any of its Third Party [*], provided, however, Corixa shall not during the term of this Agreement conduct any clinical trial in the Territory in respect of the Licensed Product or sell, market or distribute the Licensed Product in the Licensed Field in the Territory. Notwithstanding the foregoing, Corixa shall provide ZKC access to clinical data and regulatory filings controlled by Corixa related to the Licensed Product in the Licensed Field, and shall also use good faith efforts to cause any Third Party(ies) controlling any such clinical data and regulatory filings to make such access available to ZKC. 2.4 The parties acknowledge and agree that nothing in this Agreement shall restrict in any manner ZKC's ability to conduct clinical trials of any nature either inside or outside of the Licensed Field at its or any of its Third Party partner(s)' own cost and expense, provided, however, ZKC shall not during the term of this Agreement conduct any clinical trial in respect of -------- * Confidential treatment requested. the Licensed Product other than in the Territory in the Licensed Field. Notwithstanding the foregoing, ZKC shall provide Corixa access to clinical data and regulatory filings controlled by ZKC related to the Licensed Product in the Licensed Field, and shall also use good faith efforts to cause any Third Party(ies) controlling any such clinical data and regulatory filings to make such access available.

Development and Commercialization Program. 2.1 Commencing on a. UT shall be responsible for all costs and expenses for obtaining regulatory approval and commercializing Products for treatment of the Effective DateIndication, the parties including all costs of clinical trials. UT will solely and exclusively own all regulatory applications and approvals obtained by UT with respect to Products. UT will closely consult with Toray with regard to its participation in important clinical development meetings. b. UT and Toray shall collaborate in establish a Management Committee, comprised of two persons from UT and two persons from Toray, which will meet at least once a year at each party's expense to coordinate the development and commercialization marketing of Products under this Agreement, to determine the Licensed Product in the Licensed Fielddevelopment schedule, and to take such other actions as required under this Agreement. 1. The program of activities initial Product development schedule, subject to be conducted revision by each of Corixa and ZKC during the term of Management Committee, is as follows: Action Date ------ ---- Orphan-IND QIS) [ ] Phase II start [ ] Phase III start [ ] NDA filing [ ] FDA approval [ ] In the event that the Product development schedule falls more than six months behind the above initial development schedule, then Toray may at its discretion terminate this Agreement is set forth on Exhibit C (the "Development and Commercialization Program"), which shall be amended on an annual basis by mutual agreement of the parties, effective upon each anniversary of the Effective Datewithout any additional penalty to UT. 2. The Development and Commercialization Program shall include a development plan setting forth the activities currently contemplated initial quantity of Product provided by Toray to UT free of charge for use in clinical studies, subject to revision by the parties Management Committee, is up to be performed in developing the Licensed Product, as well as a description of each party's responsibilities in connection with the development and commercialization of the Licensed Product. Anything herein to the contrary notwithstanding, the timelines included in the development plan are non-binding and shall function as guidelines only for the development of Licensed Product and may be modified 100g. The Management Committee will decide from time to time by the Development Steering Committee. The parties agree that appropriate product sample requirements and the end goal of the Development and Commercialization Program shall be the expeditious clinical price on quantities exceeding 100g, to support UT's development and regulatory commercialization approval of the Licensed Product as necessary for the import, manufacture, marketing and/or sale thereof in the Territory in the Licensed Field. No material deviation in the subject matter and scope of such Development and Commercialization Program shall be made without the mutual written agreement of both partiesProduct. 2.2 On c. Toray shall provide UT on a timely basis and without charge all information concerning the Effective Date, ZKC agrees Product which is available to diligently undertake, [*], pre-clinical Toray and clinical development and commercialization of the Licensed Product within the Territory as determined which is reasonably required by the Development Steering Committee or Commercialization Steering Committee, as applicable. ZKC shall have the right, subject UT to the terms and conditions of fulfill its obligations under this Agreement, includingincluding but not limited to, without limitationinformation relating to preclinical and clinical research, Section 3 hereofsafety, use, pharmacokinetics and efficacy, access through Toray to determine HMR European data and authority to use and submit such data to the clinical development and commercialization plan FDA to the extent legally required, etc. In the event that UT uses information from other licensees of Toray, UT will be responsible for the Licensed Product in the Territorypayment of reasonable compensation to such licensee through Toray. 2.3 The parties acknowledge d. UT shall disclose to Toray on a timely basis and agree that nothing in this Agreement shall restrict in any manner Corixa's ability to conduct without charge all Product information (including but not limited to, clinical trials of any nature either inside studies, ADR, GCP, preparation for registration, NDA filing, FDA approval, US market PMS, safety issues) which UT acquires or outside of the Licensed Field [*] or any of its Third Party [*], provided, however, Corixa shall not will acquire during the term of this Agreement conduct any clinical trial in UT agrees that Toray may use such information outside the Territory in respect free of charge. In the Licensed Product event that Toray grants the right to use such information to a Third Party except Yamanouchi Pharmaceutical Co., LTD. and Kaken Pharmaceutical Co., LTD. outside the Territory or selluses such information itself within the Territory, market Toray will be responsible for payment of reasonable compensation to UT e. Neither UT nor Toray shall appoint a Third Party to promote or distribute Product under UT's marketing rights approved by the Licensed Product in FDA, without the Licensed Field in the Territoryother's approval. Notwithstanding the foregoing, Corixa shall provide ZKC access in the event that UT fails to clinical data and regulatory filings controlled by Corixa related to the Licensed achieve at least [ ] annual Net Sales of Product in each year in and after the Licensed Fieldthird fill sales year, and then the Management Committee shall also use good faith efforts have the right, after frill discussion, to cause any appoint a promoting company. In the event that the Management Committee is unable to reach agreement on the identity of such Third Party(ies) controlling any Party promoting company, Toray shall have the right to appoint such clinical data and regulatory filings to make such access available to ZKCcompany. 2.4 The parties acknowledge f. In the event that UT desires to market and/or advertise the Product for off-label use, UT shall discuss with Toray such off-label use and agree that nothing get the approval of it from Toray in this Agreement shall restrict in any manner ZKC's ability to conduct clinical trials of any nature either inside or outside of the Licensed Field at its or any of its Third Party partner(s)' own cost and expense, provided, however, ZKC shall not during the term of this Agreement conduct any clinical trial in respect of -------- * Confidential treatment requested. the Licensed Product other than in the Territory in the Licensed Field. Notwithstanding the foregoing, ZKC shall provide Corixa access to clinical data and regulatory filings controlled by ZKC related to the Licensed Product in the Licensed Field, and shall also use good faith efforts to cause any Third Party(ies) controlling any such clinical data and regulatory filings to make such access availableadvance.

Development and Commercialization Program. 2.1 Commencing on a. UT shall be responsible for all costs and expenses for obtaining regulatory approval and commercializing Products for treatment of the Effective DateIndication, the parties including all costs of clinical trials. UT will solely and exclusively own all regulatory applications and approvals obtained by UT with respect to Products. UT will closely consult with Toray with regard to its participation in important clinical development meetings. b. UT and Toray shall collaborate in establish a Management Committee, comprised of two persons from UT and two persons from Toray, which will meet at least once a year at each party's expense to coordinate the development and commercialization marketing of the Licensed Product in the Licensed Field. The program of activities to be conducted by each of Corixa and ZKC during the term of the Agreement is set forth on Exhibit C (the "Development and Commercialization Program"), which shall be amended on an annual basis by mutual agreement of the parties, effective upon each anniversary of the Effective Date. The Development and Commercialization Program shall include a development plan setting forth the activities currently contemplated by the parties to be performed in developing the Licensed Product, as well as a description of each party's responsibilities in connection with the development and commercialization of the Licensed Product. Anything herein to the contrary notwithstanding, the timelines included in the development plan are non-binding and shall function as guidelines only for the development of Licensed Product and may be modified from time to time by the Development Steering Committee. The parties agree that the end goal of the Development and Commercialization Program shall be the expeditious clinical development and regulatory approval of the Licensed Product as necessary for the import, manufacture, marketing and/or sale thereof in the Territory in the Licensed Field. No material deviation in the subject matter and scope of such Development and Commercialization Program shall be made without the mutual written agreement of both parties. 2.2 On the Effective Date, ZKC agrees to diligently undertake, [*], pre-clinical and clinical development and commercialization of the Licensed Product within the Territory as determined by the Development Steering Committee or Commercialization Steering Committee, as applicable. ZKC shall have the right, subject to the terms and conditions of Products under this Agreement, including, without limitation, Section 3 hereof, to determine the Product development schedule, and to take such other actions as required under this Agreement. 1. The initial Product development schedule, subject to revision by the Management Committee, is as follows: Action Date ------ ---- Orphan-IND (US) [ ] Phase II start [ ] Phase III start [ ] NDA filing [ ] FDA approval [ ] In the event that the Product development schedule falls more than six months behind the above initial development schedule, then Toray may at its discretion terminate this Agreement without any additional penalty to UT. 2. The initial quantity of Product provided by Toray to UT free of charge for use in clinical studies, subject to revision by the Management Committee, is up to 100g. The Management Committee will decide from time to timethe appropriate product sample requirements and the price on quantities exceeding 100g, to support UT's development and commercialization plan for approval of the Licensed Product in the TerritoryProduct. 2.3 The parties acknowledge c. Toray shall provide UT on a timely basis and agree without charge all information concerning the Product which is available to Toray and which is reasonably required by UT to fulfill its obligations under this Agreement, including but not limited to, information relating to preclinical and clinical research, safety, use, pharmacokinetics and efficacy, access through Toray to HMR European data and authority to use and submit such data to the FDA to the extent legally required, etc. In the event that nothing in this Agreement UT uses information from other licensees of Toray, UT will be responsible for payment of reasonable compensation to such licensee through Toray. d. UT shall restrict in any manner Corixa's ability disclose to conduct Toray on a timely basis and without charge all Product information (including but not limited to, clinical trials of any nature either inside studies, ADR, GCP, preparation for registration, NDA filing, FDA approval, US market, PMS, safety issues) which UT acquires or outside of the Licensed Field [*] or any of its Third Party [*], provided, however, Corixa shall not will acquire during the term of this Agreement conduct any clinical trial in Agreement. UT agrees that Toray may use such information outside the Territory in respect free of charge. In the Licensed Product or sell, market or distribute event that Toray grants the Licensed Product in the Licensed Field in the Territory. Notwithstanding the foregoing, Corixa shall provide ZKC access right to clinical data and regulatory filings controlled by Corixa related use such information to the Licensed Product in the Licensed Field, and shall also use good faith efforts to cause any Third Party(ies) controlling any such clinical data and regulatory filings to make such access available to ZKC. 2.4 The parties acknowledge and agree that nothing in this Agreement shall restrict in any manner ZKC's ability to conduct clinical trials of any nature either inside or outside of the Licensed Field at its or any of its a Third Party partner(s)' own cost and expense, provided, however, ZKC shall not during the term of this Agreement conduct any clinical trial in respect of -------- * Confidential treatment requestedexcept Yamanouchi Parmaceutical Co.,LTD. the Licensed Product other than in the Territory in the Licensed Field. Notwithstanding the foregoing, ZKC shall provide Corixa access to clinical data and regulatory filings controlled by ZKC related to the Licensed Product in the Licensed Field, and shall also use good faith efforts to cause any Third Party(ies) controlling any such clinical data and regulatory filings to make such access available.and

Development and Commercialization Program. 2.1 Commencing on a. UT shall be responsible for all costs and expenses for obtaining regulatory approval and commercializing Products for treatment of the Effective DateIndication, the parties including all costs of clinical trials. UT will solely and exclusively own all regulatory applications and approvals obtained by UT with respect to Products. UT will closely consult with Toray with regard to its participation in important clinical development meetings. b. UT and Toray shall collaborate in establish a Management Committee, comprised of two (2) persons from UT and two (2) persons from Toray, which will meet at least once a year at each party's expense to coordinate the development and commercialization marketing of the Licensed Products under this Agreement, to determine the Product in the Licensed Fielddevelopment schedule, and to take such other actions as required under this Agreement. (1). The program initial Product development schedule, subject to revision by the Management Committee, is as follows: Action Date ------ ---- Orphan-IND (US) [______________] Phase II start [______________] Phase III start [______________] NDA filing [______________] FDA approval [______________] In the event that the Product development schedule falls more than six (6) months behind the above initial development schedule, then Toray may at its discretion terminate this Agreement without any additional penalty to UT. The above schedule shall be extended same days as delayed in delivery to UT by Toray of activities adequate documentation of sustained release performance in humans and the cGMP Product supply from [______________] and [______________], respectively. (2). The initial quantity of the Product provided by Toray to UT free of charge for use in clinical studies, subject to revision by the Management Committee, is up to one hundred grams (100g). The Management Committee will decide from time to time the appropriate product sample requirements and the price on quantities exceeding one hundred grams (100g), to support UT's development and commercialization approval of the Product. c. Toray shall provide UT on a timely basis and without charge all information concerning the Product which is available to Toray and which is reasonably required by UT to fulfill its obligations under this Agreement, including but not limited to, information relating to preclinical and clinical research, safety, use, pharmacokinetics and efficacy, access through Toray to HMR European data and authority to use and submit such data to the FDA to the extent legally required, etc. In the event that UT uses information from other licensees of Toray, UT will be conducted by each responsible for payment of Corixa reasonable compensation to such licensee through Toray. d. UT shall disclose to Toray on a timely basis and ZKC without charge all Product information (including but not limited to, clinical studies, ADR, GCP, preparation for registration, NDA filing, FDA approval, US market, PMS, safety issues) which UT acquires or will acquire during the term of this Agreement. UT agrees that Toray may use such information outside the Agreement is set forth on Exhibit C (Territory free of charge. In the "Development event that Toray grants the right to use such information to a Third Party except Yamanouchi Parmaceutical Co.,LTD. and Commercialization Program")Kaken Parmaceutical Co.,LTD. outside the Territory or uses such information itself and grants the right to use such Information to a Third Party within the Territory, which Toray will be responsible for payment of reasonable compensation to UT. e. Neither UT nor Toray shall be amended on an annual basis by mutual agreement of appoint a Third Party to promote or distribute the parties, effective upon each anniversary of the Effective Date. The Development and Commercialization Program shall include a development plan setting forth the activities currently contemplated Product under UT's marketing rights approved by the parties to be performed in developing FDA, without the Licensed Productother's approval. Notwithstanding the foregoing, as well as a description of each party's responsibilities in connection with the development and commercialization of the Licensed Product. Anything herein to the contrary notwithstanding, the timelines included in the development plan are non-binding event that UT fails to achieve at least [______________] Dollars annual Net Sales of Product in each year in and shall function as guidelines only for after the development of Licensed Product and may be modified from time to time by third full Sales Year, then the Development Steering Committee. The parties agree that the end goal of the Development and Commercialization Program shall be the expeditious clinical development and regulatory approval of the Licensed Product as necessary for the import, manufacture, marketing and/or sale thereof in the Territory in the Licensed Field. No material deviation in the subject matter and scope of such Development and Commercialization Program shall be made without the mutual written agreement of both parties. 2.2 On the Effective Date, ZKC agrees to diligently undertake, [*], pre-clinical and clinical development and commercialization of the Licensed Product within the Territory as determined by the Development Steering Management Committee or Commercialization Steering Committee, as applicable. ZKC shall have the right, subject to the terms and conditions of this Agreement, including, without limitation, Section 3 hereofafter full discussion, to determine appoint a promoting company. In the clinical development and commercialization plan for event that the Licensed Product in Management Committee is unable to reach agreement on the Territoryidentity of such Third Party promoting company, Toray shall have the right to appoint such company. 2.3 The parties acknowledge f. In the event that UT desires to market and/or advertise the Product for off-label use, UT shall discuss with Toray such off-label use and agree that nothing get the approval of it from Toray in this Agreement shall restrict in any manner Corixa's ability to conduct clinical trials of any nature either inside or outside of the Licensed Field [*] or any of its Third Party [*], provided, however, Corixa shall not during the term of this Agreement conduct any clinical trial in the Territory in respect of the Licensed Product or sell, market or distribute the Licensed Product in the Licensed Field in the Territory. Notwithstanding the foregoing, Corixa shall provide ZKC access to clinical data and regulatory filings controlled by Corixa related to the Licensed Product in the Licensed Field, and shall also use good faith efforts to cause any Third Party(ies) controlling any such clinical data and regulatory filings to make such access available to ZKCadvance . 2.4 The parties acknowledge and agree that nothing in this Agreement shall restrict in any manner ZKC's ability to conduct clinical trials of any nature either inside or outside of the Licensed Field at its or any of its Third Party partner(s)' own cost and expense, provided, however, ZKC shall not during the term of this Agreement conduct any clinical trial in respect of -------- * Confidential treatment requested. the Licensed Product other than in the Territory in the Licensed Field. Notwithstanding the foregoing, ZKC shall provide Corixa access to clinical data and regulatory filings controlled by ZKC related to the Licensed Product in the Licensed Field, and shall also use good faith efforts to cause any Third Party(ies) controlling any such clinical data and regulatory filings to make such access available.