Further Development. Within ninety (90) days of the completion of a pilot biostudy and delivery of the final report on the results of the pilot biostudy("Further Development Option Deadline"), Pacific shall have, upon verification of Pacific's Commercial Capabilities and written notification to IntelGenx, the option to continue, at its expense, any further development of the Product deemed necessary for commercialisation of the Product whilst being, subject to Sections 3.4 and 5.1 solely responsible financially and/or otherwise for the timely completion of all activities, necessary for the commercialisation of the Product, and, for the avoidance of doubt, with all royalty obligations as per Section 8, responsibilities as per Section 2 and license grants as per Section 5, described herein remaining in effect ("Further Development Option"). In the event that Pacific elects to exercise its Further Development Option, and the Parties will enter into good faith negotiations to finalize a development and supply agreement. Notwithstanding the foregoing IntelGenx shall at all times retain all manufacturing rights related to the Licensed Application and/or Product and shall, in furtherance to Sections 3.4 and 5.1, be responsible, at Pacific's cost, upon receipt by IntelGenx of a Purchase order for product from the Commercial Partner, for carrying out all manufacturing activities related to the Product, either itself or, subject to approval by Pacific, such approval not to be unreasonably withheld, delayed or conditioned, through a qualified third party manufacturer. In the event that Pacific elects not to exercise its Further Development Option, or in the event that Pacific is unable to provide reasonable evidence by the Further Development Option Deadline of Pacific's Commercial Capabilities, Pacific shall immediately send IntelGenx written notification of such. This notice is deemed as an offer by Pacific to IntelGenx, to fully transfer title, interest, ownership and/or control of the Project and all intellectual property and intellectual property rights related thereto. IntelGenx shall the have the right, at its sole discretion to accept full title, interest, ownership and/or control thereto and complete, at its own expense, all activities necessary to successfully commercialize the Product, without liability to Pacific as to the result of any actions taken by IntelGenx, its Affiliates, licensee(s) and/or any sublicensee ("Transfer Option"). Notwithstanding any text to the contrary set forth herein, in the event that IntelGenx exercises its Transfer Option Pacific shall, other than costs incurred before IntelGenx exercises its Transfer Option, have no further financial responsibility or involvement in further development of the Project. In the event that IntelGenx elects not to exercise its Transfer Option, this Agreement shall terminate, and Pacific shall, within forty five (45) days of Pacific receiving written notification oflntelGenx' decision not to exercise its Transfer Option, pay IntelGenx an amount equal to the Internal Costs. Notwithstanding termination of the Agreement, all royalty obligations shall continue.
Appears in 2 contracts
Sources: Development and Commercialisation Agreement (Pacific Therapeutics Ltd.), Development and Commercialisation Agreement (Pacific Therapeutics Ltd.)
Further Development. Within ninety (90) days of the completion of a pilot biostudy pivotal bioequivelency study and delivery of the final report on the results of the pilot biostudy("Further pivotal bio-equivalency study("Further Development Option Deadline"), Pacific shall have, upon verification of Pacific's Commercial Capabilities and written notification to IntelGenxGlobe, the option to continue, at its expense, any further development of the Product deemed necessary for commercialisation of the Product whilst being, subject to Sections 3.4 and 5.1 solely responsible financially and/or otherwise for the timely completion of all activities, necessary for the commercialisation of the Product, and, for the avoidance of doubt, with all royalty obligations as per Section 8, responsibilities as per Section 2 and license grants as per Section 5, described herein remaining in effect ("Further Development Option"). In the event that Pacific elects to exercise its Further Development Option, and the Parties Pacific will enter into good faith negotiations to finalize a development and supply agreement. Notwithstanding the foregoing IntelGenx shall have at all times retain all manufacturing rights related to the Licensed Application and/or Product and shall, in furtherance to Sections 3.4 and 5.1, be responsible, at Pacific's cost, upon receipt by IntelGenx of a Purchase order for product from the Commercial Partner, for carrying out all manufacturing activities related to the Product, either itself or, subject to approval by Pacific, such approval not to be unreasonably withheld, delayed or conditioned, through a qualified third party manufacturer. In the event that Pacific elects not to exercise its Further Development Option, or in the event that Pacific is unable to provide reasonable evidence by the Further Development Option Deadline of Pacific's Commercial Capabilities, Pacific shall immediately send IntelGenx Globe written notification of such. This notice is deemed as an offer by Pacific to IntelGenxGlobe, to fully transfer title, interest, ownership and/or control of the Project and all Globe intellectual property and Globe intellectual property rights related thereto. IntelGenx Globe shall the have the right, at its sole discretion to accept full title, interest, ownership and/or control thereto and complete, at its own expense, all activities necessary to successfully commercialize the Product, without liability to Pacific as to the result of any actions taken by IntelGenxGlobe, its Affiliates, licensee(s) and/or any sublicensee ("Transfer Option"). Notwithstanding any text to the contrary set forth herein, in the event that IntelGenx Globe exercises its Transfer Option Pacific shall, other than costs incurred before IntelGenx Globe exercises its Transfer Option, have no further financial responsibility or involvement in further development of the Project. In the event that IntelGenx Globe elects not to exercise its Transfer Option, this Agreement shall terminate, and Pacific shall, within forty five (45) days of Pacific receiving written notification oflntelGenx' decision not to exercise its Transfer Option, pay IntelGenx an amount equal to the Internal Costs. Notwithstanding termination of the Agreement, all royalty obligations shall continue.
Appears in 1 contract
Sources: Development and Commercialisation Agreement (Pacific Therapeutics Ltd.)