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There must be specific individuals who assume the responsibility and accountability for the success of the partnership/venture. There may be individuals who are assigned the responsibility, accountability and authority for a specific portion of the project, such as R&D, Marketing, Finance, Legal, etc., but there must be a person who assumes overall project responsibility and accountability. |
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Defining how problems, conflicts and concerns will be managed and rectified and who will be assigned the responsibility and authority to ensure that they are. |
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Clearly defining who owns the data and where it will reside. |
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Describing who owns the regulatory submission. |
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Defining who is the liaison between the alliance, the regulatory agencies, and the role of each of the partners. |
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Defining the managerial structure, specifying that group's responsibility and authority over the various aspects of the alliance's operation. The managerial structure must be straightforward and well understood. The alliance's managerial structure should be developed and geared to ensure the shared success of the venture over the long term. In this case, the simpler and clearer the structure, the better. This particular point needs to be tied to and clearly integrated into any discussion about procedures and processes for operating the alliance. |
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There are always a few issues and questions that cannot be easily categorized but should not be overlooked. Some of them are |
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defining a plan of action for the course to take if the project fails; |
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defining how costs will be budgeted, monitored, accounted for, verified, shared or reimbursed, if necessary; |
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specifying, to the degree of certainty possible, if there will need to be an additional investment over the current R&D budget by entering into the alliance and/or how current R&D budgets will be allocated to the alliance project; |
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defining, up-front, where the money will come from, both partners or one. |
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E.
Project Team Structure, Management, and Operation |
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One of the key aspects in defining how an alliance will work is defining how the project will be managed. In most cases, a team is created to oversee the |
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