Common use of Development Program Clause in Contracts

Development Program. 1.1 Fuisz and Kos shall jointly undertake using reasonable best efforts a Development Program to develop one or more Products for Commercial Sale. It is understood that this Development Program is primarily for the purposes of developing and producing Products and shall be carried out generally in accordance with Appendix B. 1.2 Each party shall appoint a Program Manager for overall management of the Development Program and such Program Managers shall by mutual agreement provide the direction of the program and the scope of work to be undertaken under the Development Program; provided, however, that Kos shall determine the focus of work which the Program Managers mutually agree can be carried out under the Development Program, within the guidelines set forth in Appendix B. The initial Program Manager for Kos shall be designated within thirty (30) days and the initial Program Manager for Fuisz shall be Martynn Sheehan. ▇▇▇▇ ▇▇▇▇▇ ▇▇▇ change the designated Program Manager upon written notice to the other party of such change. 1.3 During the term of the Development Program Fuisz shall periodically provide to Kos samples of materials for evaluation by Kos. Kos shall promptly evaluate such samples and provide guidance to Fuisz for further work based on the results of such evaluations. During the Development Program term, Program Managers or representatives of the parties shall meet from time to time to discuss planning and progress of the Development Program to carry out efficient and effective activities. Fuisz shall provide project updates to Kos verbally and/or in written form every four (4) weeks during the Development Program, and shall provide a written report upon completion of the Development Program. All such discussions and activities shall be considered as carried out under the Development Program. 1.4 Kos shall supply to Fuisz, at Kos's cost and expense, materials including IS-5-MN which Kos believes are essential for carrying out the Development Program. All such materials supplied by Kos shall be materials approved for human uses unless otherwise specifically designated and Kos shall supply MSDS sheets where necessary for the processing of such materials. Fuisz shall advise Kos from time to time of its requirements for such materials for the Development Program. 1.5 Upon termination of each Phase of the Development Program, Fuisz shall provide to Kos quantities of prototype Products processed using Technology which demonstrate the best results obtained under the Development Program. Kos shall provide to Fuisz all data, information and conclusions generated during the Development Program relating to the Development Program and/or Technology including without limitation ******************** and any other mutually agreed pre-defined data, and Fuisz shall have the ****************** to use all such data, information and conclusions; provided, however, that Fuisz shall not utilize such data, information and conclusions to the detriment of the competitive position of Kos or inappropriately identify Kos in any publicity concerning same. 1.6 In the event special processing or manufacturing equipment specifically modified or adapted for use with Technology is requested by Kos to be used under the Development Program, Kos shall provide such equipment to Fuisz for the duration of the Development Program. 1.7 All activities in connection with the Development Program shall be carried out by each party in strict compliance with any applicable federal, state or local laws, regulations or guidelines governing such activities. 1.8 In addition to the funding under Article 3, Kos shall pay for the cost of all materials including IS-5-MN used in the Development Program and approved by Kos (to the extent such materials are not provided and fully paid by Kos), and Kos shall pay for the costs of all shipping, packing, customs, duties and customs clearances associated with shipment of materials and/or equipment to or from Fuisz or for, or resulting from work under, the Development Program. In addition, Kos shall pay for the reasonable costs of travel of Fuisz personnel at the prior request and approval of Kos in connection with meetings, activities or reviews of activities under the Development Program. 1.9 All equipment, supplies and other items purchased by either party for the conduct of the Development Program, shall be the sole and exclusive property of the purchasing party. For purposes hereof, all such items purchased by Fuisz with funds provided by Kos shall be deemed to be items purchased and owned by *****.

Development Program. 1.1 Fuisz and Kos shall jointly undertake using reasonable best efforts a Development Program to develop one or more Products for Commercial Sale. It is understood that this Development Program is primarily for the purposes of developing and producing Products and shall be carried out generally in accordance with Appendix B. 1.2 Each party shall appoint a Program Manager for overall management of the Development Program and such Program Managers shall by mutual agreement provide the direction of the program and the scope of work to be undertaken under the Development Program; provided, however, that Kos shall determine the focus of work which the Program Managers mutually agree can be carried out under the Development Program, within the guidelines set forth in Appendix B. The initial Program Manager for Kos shall be designated within thirty (30) days and the initial Program Manager for Fuisz shall be Martynn Sheehan. ▇▇▇▇ ▇▇▇▇▇ ▇▇▇ change the designated Program Manager upon written notice to the other party of such change. 1.3 During the term of the Development Program Fuisz shall periodically provide to Kos samples of materials for evaluation by Kos. Kos shall promptly evaluate such samples and provide guidance to Fuisz for further work based on the results of such evaluations. During the Development Program term, Program Managers or representatives of the parties shall meet from time to time to discuss planning and progress of the Development Program to carry out efficient and effective activities. Fuisz shall provide project updates to Kos verbally and/or in written form every four (4) weeks during the Development Program, and shall provide a written report upon completion of the Development Program. All such discussions and activities shall be considered as carried out under the Development Program. 1.4 Kos shall supply to Fuisz, at Kos's cost and expense, materials including IS-5-MN Captopril which Kos believes are essential for carrying out the Development Program. All such materials supplied by Kos shall be materials approved for human uses unless otherwise specifically designated and Kos shall supply MSDS sheets where necessary for the processing of such materials. Fuisz shall advise Kos from time to time of its requirements for such materials for the Development Program. 1.5 Upon termination of each Phase of the Development Program, Fuisz shall provide to Kos quantities of prototype Products processed using Technology which demonstrate the best results obtained under the Development Program. Kos shall provide to Fuisz all data, information and conclusions generated during the Development Program relating to the Development Program and/or Technology including without limitation ******************** and any other mutually agreed pre-defined data, and Fuisz shall have the ****************** to use all such data, information and conclusions; provided, however, that Fuisz shall not utilize such data, information and conclusions to the detriment of the competitive position of Kos or inappropriately identify Kos in any publicity concerning same. 1.6 In the event special processing or manufacturing equipment specifically modified or adapted for use with Technology is requested by Kos to be used under the Development Program, Kos shall provide such equipment to Fuisz for the duration of the Development Program. 1.7 All activities in connection with the Development Program shall be carried out by each party in strict compliance with any applicable federal, state or local laws, regulations or guidelines governing such activities. 1.8 In addition to the funding under Article 3, Kos shall pay for the cost of all materials including IS-5-MN Captopril used in the Development Program and approved by Kos (to the extent such materials are not provided and fully paid by Kos), and Kos shall pay for the costs of all shipping, packing, customs, duties and customs clearances associated with shipment of materials and/or equipment to or from Fuisz or for, or resulting from work under, the Development Program. In addition, Kos shall pay for the reasonable costs of travel of Fuisz personnel at the prior request and approval of Kos in connection with meetings, activities or reviews of activities under the Development Program. 1.9 All equipment, supplies and other items purchased by either party for the conduct of the Development Program, shall be the sole and exclusive property of the purchasing party. For purposes hereof, all such items purchased by Fuisz with funds provided by Kos shall be deemed to be items purchased and owned by *****.

Development Program. 1.1 Fuisz and Kos shall jointly undertake using reasonable best efforts a Development Program to develop one or more Products for Commercial Sale. It is understood that this Development Program is primarily for the purposes of developing and producing Products and shall be carried out generally in accordance with Appendix B. 1.2 Each party shall appoint a Program Manager for overall management of the Development Program and such Program Managers shall by mutual agreement provide the direction of the program and the scope of work to be undertaken under the Development Program; provided, however, that Kos shall determine the focus of work which the Program Managers mutually agree can be carried out under the Development Program, within the guidelines set forth in Appendix B. The initial Program Manager for Kos shall be designated within thirty (30) days and the initial Program Manager for Fuisz shall be Martynn Sheehan***************. ▇▇▇▇ ▇▇▇▇▇ ▇▇▇ Each party may change the designated Program Manager upon written notice to the other party of such change. 1.3 During the term of the Development Program Fuisz shall periodically provide to Kos samples of materials for evaluation by Kos. Kos shall promptly evaluate such samples and provide guidance to Fuisz for further work based on the results of such evaluations. During the Development Program term, Program Managers or representatives of the parties shall meet from time to time to discuss planning and progress of the Development Program to carry out efficient and effective activities. Fuisz shall provide project updates to Kos verbally and/or in written form every four (4) weeks ******************** during the Development Program, and shall provide a written report upon completion of the Development Program. All such discussions and activities shall be considered as carried out under the Development Program. 1.4 Kos shall supply to Fuisz, at Kos's cost and expense, materials including IS-5-MN which Kos believes are essential for carrying out the Development Program. All such materials supplied by Kos shall be materials approved for human uses unless otherwise specifically designated and Kos shall supply MSDS sheets where necessary for the processing of such materials. Fuisz shall advise Kos from time to time of its requirements for such materials for the Development Program. 1.5 Upon termination of each Phase of the Development Program, Fuisz shall provide to Kos quantities of prototype Products processed using Technology which demonstrate the best results obtained under the Development Program. Kos shall provide to Fuisz all data, information and conclusions generated during the Development Program relating to the Development Program and/or Technology including without limitation ******************** and any other mutually agreed pre-defined data, and Fuisz shall have the ****************** to use all such data, information and conclusions; provided, however, that Fuisz shall not utilize such data, information and conclusions to the detriment of the competitive position of Kos or inappropriately identify Kos in any publicity concerning same. 1.6 In the event special processing or manufacturing equipment specifically modified or adapted for use with Technology is requested by Kos to be used under the Development Program, Kos shall provide such equipment to Fuisz for the duration of the Development Program. 1.7 All activities in connection with the Development Program shall be carried out by each party in strict compliance with any applicable federal, state or local laws, regulations or guidelines governing such activities. 1.8 In addition to the funding under Article 3, Kos shall pay for the cost of all materials including IS-5-MN used in the Development Program and approved by Kos (to the extent such materials are not provided and fully paid by Kos), and Kos shall pay for the costs of all shipping, packing, customs, duties and customs clearances associated with shipment of materials and/or equipment to or from Fuisz or for, or resulting from work under, the Development Program. In addition, Kos shall pay for the reasonable costs of travel of Fuisz personnel at the prior request and approval of Kos in connection with meetings, activities or reviews of activities under the Development Program. 1.9 All equipment, supplies and other items purchased by either party for the conduct of the Development Program, shall be the sole and exclusive property of the purchasing party. For purposes hereof, all such items purchased by Fuisz with funds provided by Kos shall be deemed to be items purchased and owned by *****.

Development Program. 1.1 Fuisz and Kos shall jointly undertake using reasonable best efforts a Development Program to develop one or more Products for Commercial Sale. It is understood that this Development Program is primarily for the purposes of developing and producing Products and shall be carried out generally in accordance with Appendix B. 1.2 Each party shall appoint a Program Manager for overall management of the Development Program and such Program Managers shall by mutual agreement provide the direction of the program and the scope of work to be undertaken under the Development Program; provided, however, that Kos shall determine the focus of work which the Program Managers mutually agree can be carried out under the Development Program, within the guidelines set forth in Appendix B. The initial Program Manager for Kos shall be designated within thirty (30) days and the initial Program Manager for Fuisz shall be Martynn Sheehan***************. ▇▇▇▇ ▇▇▇▇▇ ▇▇▇ Each party may change the designated Program Manager upon written notice to the other party of such change. 1.3 During the term of the Development Program Fuisz shall periodically provide to Kos samples of materials for evaluation by Kos. Kos shall promptly evaluate such samples and provide guidance to Fuisz for further work based on the results of such evaluations. During the Development Program term, Program Managers or representatives of the parties shall meet from time to time to discuss planning and progress of the Development Program to carry out efficient and effective activities. Fuisz shall provide project updates to Kos verbally and/or in written form every four (4) weeks ******************** during the Development Program, and shall provide a written report upon completion of the Development Program. All such discussions and activities shall be considered as carried out under the Development Program. 1.4 Kos shall supply to Fuisz, at Kos's cost and expense, materials including IS-5-MN Captopril which Kos believes are essential for carrying out the Development Program. All such materials supplied by Kos shall be materials approved for human uses unless otherwise specifically designated and Kos shall supply MSDS sheets where necessary for the processing of such materials. Fuisz shall advise Kos from time to time of its requirements for such materials for the Development Program. 1.5 Upon termination of each Phase of the Development Program, Fuisz shall provide to Kos quantities of prototype Products processed using Technology which demonstrate the best results obtained under the Development Program. Kos shall provide to Fuisz all data, information and conclusions generated during the Development Program relating to the Development Program and/or Technology including without limitation ******************** and any other mutually agreed pre-defined data, and Fuisz shall have the ****************** to use all such data, information and conclusions; provided, however, that Fuisz shall not utilize such data, information and conclusions to the detriment of the competitive position of Kos or inappropriately identify Kos in any publicity concerning same. 1.6 In the event special processing or manufacturing equipment specifically modified or adapted for use with Technology is requested by Kos to be used under the Development Program, Kos shall provide such equipment to Fuisz for the duration of the Development Program. 1.7 All activities in connection with the Development Program shall be carried out by each party in strict compliance with any applicable federal, state or local laws, regulations or guidelines governing such activities. 1.8 In addition to the funding under Article 3, Kos shall pay for the cost of all materials including IS-5-MN Captopril used in the Development Program and approved by Kos (to the extent such materials are not provided and fully paid by Kos), and Kos shall pay for the costs of all shipping, packing, customs, duties and customs clearances associated with shipment of materials and/or equipment to or from Fuisz or for, or resulting from work under, the Development Program. In addition, Kos shall pay for the reasonable costs of travel of Fuisz personnel at the prior request and approval of Kos in connection with meetings, activities or reviews of activities under the Development Program. 1.9 All equipment, supplies and other items purchased by either party for the conduct of the Development Program, shall be the sole and exclusive property of the purchasing party. For purposes hereof, all such items purchased by Fuisz with funds provided by Kos shall be deemed to be items purchased and owned by *****.

Development Program. 1.1 Fuisz and Kos 4.1.1 The Parties shall jointly undertake using reasonable best efforts a Development Program to develop one or more Products for Commercial Sale. It is understood that this Development Program is primarily for the purposes development of developing and producing Products and shall be carried out generally Licensed Product in accordance with Appendix B. 1.2 Each party shall appoint a Program Manager for overall management of the terms and conditions set forth in this Agreement and the Development Program Plan. SLI shall furnish, maintain and such Program Managers shall by mutual agreement provide preserve suitable and sufficient facilities and personnel for the direction of the program and the scope of work to be undertaken under accomplished by SLI hereunder, use its reasonable commercial efforts to accomplish the Development ProgramPlan within the time described therein in a commercially reasonable, diligent and workmanlike manner and in compliance in all material respects with the standards, laws, rules and regulations of the FDA [*] over SLI’s activities. 4.1.2 Each Development Plan shall include a budget for the proposed development activities set forth in such plan, which shall be determined prior to the anticipated commencement of the proposed development activities. For activities to be performed by SLI, Indevus shall pay to SLI the sums set out in the Development Plan on a mutually agreed upon schedule payable within 30 days of Indevus’ receipt of SLI’s invoice detailing the tasks carried out by SLI pursuant to the Development Plan; provided, however, that Kos in no event shall determine the focus Indevus be responsible for or be required to reimburse SLI for activities not mutually agreed upon in writing. Indevus shall be responsible for all reasonable out of work which the Program Managers mutually agree can be carried out under pocket costs and/or expenses associated with the Development Program, within the guidelines set forth in Appendix B. The initial Program Manager for Kos shall be designated within thirty (30) days Plan upon submission of appropriate back-up documentation and the initial Program Manager for Fuisz shall be Martynn Sheehan. ▇▇▇▇ ▇▇▇▇▇ ▇▇▇ change the designated Program Manager upon written notice to the other party of such change. 1.3 During the term of the Development Program Fuisz shall periodically provide to Kos samples of materials for evaluation by Kos. Kos shall promptly evaluate such samples and provide guidance to Fuisz for further work based on the results of such evaluations. During the Development Program term, Program Managers or representatives of the parties shall meet from time to time to discuss planning and progress of the Development Program to carry out efficient and effective activities. Fuisz shall provide project updates to Kos verbally and/or in written form every four (4) weeks during the Development Program, and shall provide a written report upon completion of the Development Program. All such discussions and activities shall be considered as carried out under the Development Program. 1.4 Kos shall supply to Fuisz, at Kos's cost and expense, materials including IS-5-MN which Kos believes are essential for carrying out the Development Program. All such materials supplied by Kos shall be materials approved for human uses unless otherwise specifically designated and Kos shall supply MSDS sheets where necessary for the processing of such materials. Fuisz shall advise Kos from time to time of its requirements for such materials for the Development Program. 1.5 Upon termination of each Phase of the Development Program, Fuisz shall provide to Kos quantities of prototype Products processed using Technology which demonstrate the best results obtained under the Development Program. Kos shall provide to Fuisz all data, information and conclusions generated during the Development Program relating to the Development Program and/or Technology including without limitation ******************** and any other mutually agreed pre-defined data, and Fuisz shall have the ****************** to use all such data, information and conclusions; provided, however, that Fuisz no expenses in excess of [*], or such other amount as may be subsequently agreed to by the Parties, shall not utilize be incurred by SLI or reimbursed by Indevus unless SLI obtained Indevus’ written consent prior to incurring such dataexpense. Such costs and expenses shall include required raw materials, information excipients, supplies, columns, standards, chemicals, travel and conclusions to the detriment shipping expenses. 4.1.3 Indevus shall be responsible for providing adequate supplies of the competitive position Compound, which will be supplied to SLI free of Kos or inappropriately identify Kos charge in any publicity concerning same. 1.6 accordance with the Development Plan and in accordance with cGMP. In the event special processing that the active ingredient is not delivered to SLI or manufacturing equipment specifically modified or adapted for use with Technology is requested by Kos to be used under not provided within the required timescale the Development ProgramPlan will be extended accordingly. SLI shall be responsible for and shall manufacture and supply Licensed Product to Indevus, Kos shall provide such equipment to Fuisz for the duration of the Development Program. 1.7 All activities at Indevus’ expense, in connection accordance with the Development Program shall be carried out by each party Plan for clinical trials conducted under a Development Plan, in strict accordance with the Specifications and in compliance with any cGMP and all other applicable federal, state or local laws, laws and regulations or guidelines governing and such activitiesother terms to be mutually agreed upon between the Parties. 1.8 In addition 4.1.4 Should Indevus or any Indevus Affiliate or any Sublicensee elect to the funding under Article 3, Kos shall pay for the cost of all materials including IS-5-MN used pursue any development that requires any change in the Development Program and approved by Kos (to formulation of the extent such materials are not provided and fully paid by Kos)Licensed Product, and Kos shall pay for the costs of SLI will conduct all shipping, packing, customs, duties and customs clearances associated with shipment of materials and/or equipment to or from Fuisz or for, or resulting from work under, the Development Program. In addition, Kos shall pay for the reasonable costs of travel of Fuisz personnel at the prior request and approval of Kos in connection with meetings, activities or reviews of future development activities under the a mutually agreed upon Development ProgramPlan. 1.9 All equipment, supplies and other items purchased by either party for the conduct of the Development Program, shall be the sole and exclusive property of the purchasing party. For purposes hereof, all such items purchased by Fuisz with funds provided by Kos shall be deemed to be items purchased and owned by *****.