Common use of Termination by GSK Clause in Contracts

Termination by GSK. At any time after one (1) year after the ------------------ Effective Date, GSK may terminate this Agreement in its sole discretion on a country-by-country basis, or in its entirety, by giving Unigene at least ninety (90) days written notice (with such written notice to include a reasonably detailed explanation of the reasons for the termination, including the applicable provision of this Section 10.4 and the supporting evidence therefore) thereof at any time for any of the reasons set forth below based on a reasonable determination by GSK, using the same standards GSK would use in assessing whether or not to continue development or commercialization of a product of its own making in its own portfolio, that: (i) the Licensed Product has: (1) safety concerns which do not justify continued development or commercialization, would significantly disadvantage the Licensed Product with respect to other compounds or products and/or would significantly reduce the value of the opportunity, all in GSK's reasonable business determination; or (2) efficacy concerns which do not justify continued development or commercialization, or would significantly disadvantage the Licensed Product with respect to other compounds or products and/or would significantly reduce the value of the opportunity, all in GSK's reasonable business determination; or (3) substantial difficulty in meeting developmental timelines; or (4) substantial increases in development costs from current projections; (ii) the cost of goods for commercial supply of Licensed Product would significantly reduce the value of the opportunity; (iii) changes to the osteoporosis market and/or the competitive environment reduce the sales forecast below a commercially viable threshold normally applied by GSK within its own portfolio; (iv) government, regulatory or another recognized institution imposes a new law or requirement, or establishes guidelines or a pattern of practice, which means: (1) the continued development or commercialization of the Licensed Product violates such a law or requirement, or (2) the value of the opportunity is significantly reduced, or (3) the pricing and/or reimbursement environment has changed in such a way as to significantly reduce the projected value of the opportunity, or (4) a condition in (i) or (iii) above becomes applicable.

Termination by GSK. At any time after one (1) year after the ------------------ Effective Date, GSK may terminate this Agreement in its sole discretion on a country-by-country basis, or in its entirety, by giving Unigene at least ninety (90) days written notice (with such written notice to include a reasonably detailed explanation of the reasons for the termination, including the applicable provision of this Section 10.4 and the supporting evidence therefore) thereof at any time for any of the reasons set forth below based on a reasonable determination by GSK, using the same standards GSK would use in assessing whether or not to continue development or commercialization of a product of its own making in its own portfolio, that: (i) the Licensed Product has: (1) safety concerns which do not justify continued development or commercialization, would significantly disadvantage the Licensed Product with respect to other compounds or products and/or would significantly reduce the value of the opportunity, all in GSK's reasonable business determination; or (2) efficacy concerns which do not justify continued development or commercialization, or would significantly disadvantage the Licensed Product with respect to other compounds or products and/or would significantly reduce the value of the opportunity, all in GSK's reasonable business determination; or (3) substantial difficulty in meeting developmental timelines; or (4) substantial increases in development costs from current projections; (ii) the cost of goods for commercial supply of Licensed Product would significantly reduce the value of the opportunity;; 40 (iii) changes to the osteoporosis market and/or the competitive environment reduce the sales forecast below a commercially viable threshold normally applied by GSK within its own portfolio; (iv) government, regulatory or another recognized institution imposes a new law or requirement, or establishes guidelines or a pattern of practice, which means: (1) the continued development or commercialization of the Licensed Product violates such a law or requirement, or (2) the value of the opportunity is significantly reduced, or (3) the pricing and/or reimbursement environment has changed in such a way as to significantly reduce the projected value of the opportunity, or (4) a condition in (i) or (iii) above becomes applicable. Notwithstanding the foregoing, GSK may not effectively terminate this Agreement under this Section 10.4 any earlier than the date on which it receives notification from Unigene that Milestone 4 has been achieved and the corresponding payment is due (in which case GSK shall owe Unigene the Milestone 4 payment) unless GSK determines that there are material safety concerns which do not justify continued development or commercialization of the Licensed Product.

Termination by GSK. At any time after one (1) year after the ------------------ Effective Date, GSK may terminate this Agreement in its sole discretion on a country-by-country basis, or in its entirety, by giving Unigene at least ninety (90) days written notice (with such written notice to include a reasonably detailed explanation of the reasons for the termination, including the applicable provision of this Section 10.4 and the supporting evidence therefore) thereof at any time for any of the reasons set forth below based on a reasonable determination by GSK, using the same standards GSK would use in assessing whether or not to continue development or commercialization of a product of its own making in its own portfolio, that: (i) the Licensed Product has: (1) safety concerns which do not justify continued development or commercialization, would significantly disadvantage the Licensed Product with respect to other compounds or products and/or would significantly reduce the value of the opportunity, all in GSK's ’s reasonable business determination; or (2) efficacy concerns which do not justify continued development or commercialization, or would significantly disadvantage the Licensed Product with respect to other compounds or products and/or would significantly reduce the value of the opportunity, all in GSK's ’s reasonable business determination; or (3) substantial difficulty in meeting developmental timelines; or (4) substantial increases in development costs from current projections; (ii) the cost of goods for commercial supply of Licensed Product would significantly reduce the value of the opportunity; (iii) changes to the osteoporosis market and/or the competitive environment reduce the sales forecast below a commercially viable threshold normally applied by GSK within its own portfolio; (iv) government, regulatory or another recognized institution imposes a new law or requirement, or establishes guidelines or a pattern of practice, which means: (1) the continued development or commercialization of the Licensed Product violates such a law or requirement, or (2) the value of the opportunity is significantly reduced, or (3) the pricing and/or reimbursement environment has changed in such a way as to significantly reduce the projected value of the opportunity, or (4) a condition in (i) or (iii) above becomes applicable.

Termination by GSK. At any time after one (1) year after the ------------------ Effective Date, GSK may terminate this Agreement in its sole discretion on a country-by-country basis, or in its entirety, by giving Unigene at least ninety (90) days written notice (with such written notice to include a reasonably detailed explanation of the reasons for the termination, including the applicable provision of this Section 10.4 and the supporting evidence therefore) thereof at any time for any of the reasons set forth below based on a reasonable determination by GSK, using the same standards GSK would use in assessing whether or not to continue development or commercialization of a product of its own making in its own portfolio, that: (i) the Licensed Product has: (1) safety concerns which do not justify continued development or commercialization, would significantly disadvantage the Licensed Product with respect to other compounds or products and/or would significantly reduce the value of the opportunity, all in GSK's reasonable business determination; or (2) efficacy concerns which do not justify continued development or commercialization, or would significantly disadvantage the Licensed Product with respect to other compounds or products and/or would significantly reduce the value of the opportunity, all in GSK's reasonable business determination; or (3) substantial difficulty in meeting developmental timelines; or (4) substantial increases in development costs from current projections; (ii) the cost of goods for commercial supply of Licensed Product would significantly reduce the value of the opportunity; (iii) changes to the osteoporosis market and/or the competitive environment reduce the sales forecast below a commercially viable threshold normally applied by GSK within its own portfolio; (iv) government, regulatory or another recognized institution imposes a new law or requirement, or establishes guidelines or a pattern of practice, which means: (1) the continued development or commercialization of the Licensed Product violates such a law or requirement, or (2) the value of the opportunity is significantly reduced, or (3) the pricing and/or reimbursement environment has changed in such a way as to significantly reduce the projected value of the opportunity, or (4) a condition in (i) or (iii) above becomes applicable. Notwithstanding the foregoing, GSK may not effectively terminate this Agreement under this Section 10.4 any earlier than the date on which it receives notification from Unigene that Milestone 4 has been achieved and the corresponding payment is due (in which case GSK shall owe Unigene the Milestone 4 payment) unless GSK determines that there are material safety concerns which do not justify continued development or commercialization of the Licensed Product.