| | | | | | | | | | | | | | |
| | Single unit of | | | | | | | | | | | | |
| | accounting to which | | | | When Obligation of | | | | | | | | |
Item per December | | deliverable is | | | | Sucampo became a | | | | | | | | |
15 response | | attributable | | Deliverable as stated per Contract | | deliverable item | | Contractual Cash Flows | | Description of Deliverable Sucampo Obligations | | Performance Period Description | | Actual dates of Perfomance period |
|
1 | | Up front License Agreement Obligations | | Deliver license of the compound SPI-0211 to Takeda (2.1) Residual component | | Obligation is established on signing of agreement. Portion attributable to Committee activities is isolated and recognized over period of performance. Residual is recognized over period of R&D efforts | | Company received a non-refundable $20 million payment from Takeda at initiaition of agreement | | Provide Takeda with an exclusive license to co-develop, use, sell, promote, offer for sale, import and distribute the Product using SPI-0211. This was accomplished upon the signing of the agreement | | The license was delivered October 2004 and will expire when the Agreement expires December 31, 2020 or is terminated. Substantial efforts to create revenue expire when Sucampo delivers research and development efforts to file for IBS-C sNDA. | | Initially, 10/29/2004 through 12/31/2006. In May, 2006, period became extended through May 31, 2007. |
| | | | | | | | | | | | | | |
7a | | | | Joint Steering Committee (“JSC”) Participation | | Obligation is established on signing of agreement. Portion attributable to Committee activity is isolated and recognized over period of performance | | | | Committee obligations are established at beginning of contract and extend through periods of performance. | | JSC is established at inception and lasts throughout December 31, 2020 | | 10/29/2004 through 12/31/2020 |
| | | | | | | | | | | | | | |
7b | | | | Joint Development Committee (“JDC”) Participation | | Obligation is established on signing of agreement. Portion attributable to Committee activity is isolated and recognized over period of performance | | | | Committee obligations are established at beginning of contract and extend through periods of performance. | | JDC is established at inception and lasts throughout the period of performance which expire when Sucampo delivers research and development efforts to file for IBS-C sNDA or extensions for additional R&D projects. | | Initially, 10/29/2004 through 12/31/2006. In May, 2006, period became extended through May 31, 2007. |
| | | | | | | | | | | | | | |
7c | | | | Joint Commercialization Committee (“JCC”) Participation | | Obligation is established on signing of agreement. Portion attributable to Committee activity is isolated and recognized over period of performance | | | | Committee obligations are established at beginning of contract and extend through periods of performance. | | JSC is established at inception and lasts throughout December 31, 2020 | | 10/29/2004 through 12/31/2020 |
| | | | | | | | | | | | | | |
7d | | | | Joint Manufacturing Committee (“JMC”) participation | | Obligation is established on signing of agreement. Portion attributable to Committee activity is isolated and recognized over period of performance | | | | Committee obligations are established at beginning of contract and extend through periods of performance. | | JMC is established at inception and lasts throughout December 31, 2020 | | 10/29/2004 through 12/31/2020 |
| | | | | | | | | | | | | | |
2a | | CIC and IBS-C | | File NDA for CIC approval | | Obligation is established on signing and is recognized over period of effort through filing of sNDA for IBS-C | | Company received a non-refundable $10 million payment from Takeda upon filing the NDA. (3/31/2005) | | Prepare and file NDA for CIC indication of Amitiza | | Substantial efforts to create revenue begin as agreeement is signed and expire when Sucampo delivers research and development efforts to file for IBS-C sNDA. | | Initially, 10/29/2004 through 12/31/2006. In May, 2006, period became extended through May 31, 2007. |
| | | | | | | | | | | | | | |
2b | | | | Initiate IBS-C indication Phase III study by enrolloing first patient | | Obligation is established on signing and is recognized over period of effort through filing of sNDA for IBS-C | | Company received a non-refundable $20 million payment from Takeda upon enrolling first IBS-C patient (May, 2005) | | Define study, have study approved by partner and FDA, recruit, qualify and enroll first study patient | | Substantial efforts to create revenue begin as agreeement is signed and expire when Sucampo delivers research and development efforts to file for IBS-C sNDA. | | Initially, 10/29/2004 through 12/31/2006. In May, 2006, period became extended through May 31, 2007. |
| | | | | | | | | | | | | | |
2c | | | | Obtain Approval from FDA for CIC indication of Amitiza | | Obligation is established on signing and is recognized over period of effort through filing of sNDA for IBS-C | | Company received a non-refundable $20 million payment from Takeda upon approval for CIC indication of Amitiza (January 31, 2006) | | Define study, have study approved by partner and FDA, recruit, qualify and enroll patients and complete efforts to file NDA | | Substantial efforts to create revenue begin as agreeement is signed and expire when Sucampo delivers research and development efforts to file for CIC sNDA. Because deliverable is inseparable from other deliverables in unit of accounting, revenue is recognized over period that Sucampo delivers research and development efforts to file for IBS-C sNDA. | | Initially, 10/29/2004 through 12/31/2006. In May, 2006, period became extended through May 31, 2007. |
| | | | | | | | | | | | | | |
2d | | | | Development for NDA submission for IBS-C (4.2(i) and 7.2). | | Obligation is established on signing and is recognized over period of effort through filing of sNDA for IBS-C | | Takeda shall fund the initial $30 million of development costs. Sucampo shall fund the next $20 million and the two shall equally share any required funding in excess of $50 million. | | Sucampo shall use its best efforts to conduct all development work necessary for an NDA submission for Constipation and c-IBS. | | Substantial efforts to create revenue begin as agreeement is signed and expire when Sucampo delivers research and development efforts to file for CIC sNDA. Because deliverable is inseparable from other deliverables in unit of accounting, revenue is recognized over period that Sucampo delivers research and development efforts to file for IBS-C sNDA. | | Initially, 10/29/2004 through 12/31/2006. In May, 2006, period became extended through May 31, 2007. Initially, 10/29/2004 through 12/31/2006. In May, 2006, period became extended through May 31, 2007. Initially, 10/29/2004 through 12/31/2006. In May, 2006, period became extended through May 31, 2007. Initially, 10/29/2004 through 12/31/2006. In May, 2006, period became extended through May 31, 2007. |