Common use of Changes to the Protocol Clause in Contracts

Changes to the Protocol. If at a future date changes in the Research or Protocol appear desirable, then such changes may be made through prior written agreement between UNC-CH and Immtech. In the event that UNC-CH and Immtech disagree regarding any such proposed change, then the Scientific Advisory Board appointed by UNC-CH to oversee the Research shall resolve such disagreement. If in the course of performing this Agreement, however, either of (a) generally accepted standards of clinical research and medical practice relating to the safety of Research Subjects, (b) a directive from the Institutional Review Board of UNC-CH with authority over the Research, or (c) a decision of the Scientific Advisory Board appointed by UNC-CH to oversee the Research, requires a deviation from the Protocol, then such standards will be followed. In such case, the party aware of the need for a deviation will immediately inform the other of the facts causing such deviation as soon as the facts are known to the party. If the aggregate amount of the costs of any and all required changes and/or deviations arising pursuant to clauses (b) or (c) of this Article 20 during the term of this Agreement, for which additional funding is not provided to Immtech by either the Foundation, UNC-CH or any third party, exceed $300,000, then Immtech may terminate this Agreement upon thirty (30) days written notice to UNC-CH.

Appears in 1 contract

Sources: Clinical Research Subcontract (Immtech Pharmaceuticals, Inc.)

Changes to the Protocol. If at a future date changes in the Research or Protocol appear desirable, then such changes may be made through prior written agreement between UNC-CH and Immtech. In the event that UNC-CH and Immtech disagree regarding any such proposed change, then the Scientific Advisory Board appointed by UNC-CH to oversee the Research shall resolve such disagreement. If in the course of performing this Agreement, however, either of (a) generally accepted standards of clinical research and medical practice relating to the safety of Research Subjects, (b) a directive from the Institutional Review Board of UNC-CH with authority over the Research, or (c) a decision of the Scientific Advisory Board appointed by UNC-CH to oversee the Research, requires a deviation from the Protocol, then such standards will be followed. In such case, the party aware of the need for a deviation will immediately inform the other of the facts causing such deviation as soon as the facts are known to the party. If the aggregate amount of the costs of any and all required changes and/or deviations arising pursuant to clauses (b) or (c) of this Article 20 during the term of this Agreement, for which additional funding is not provided to Immtech by either the ▇▇▇▇ & ▇▇▇▇▇▇▇ ▇▇▇▇▇ Foundation, UNC-CH or any third party, exceed $300,000, then Immtech may terminate this Agreement upon thirty (30) days written notice to UNC-CH.

Appears in 1 contract

Sources: Clinical Research Subcontract (Immtech International Inc)

Changes to the Protocol. If at a future date changes in the Research or Protocol appear desirable, then such changes may be made through prior written agreement between UNC-CH and Immtech. In the event that UNC-CH and Immtech disagree regarding any such proposed change, then the Scientific Advisory Board appointed by UNC-CH to oversee the Research shall resolve such disagreement. If in the course of performing this Agreement, however, either of (a) generally accepted standards of clinical research and medical practice relating to the safety of Research Subjects, (b) a directive from the Institutional Review Board of UNC-CH with authority over the Research, or (c) a decision of the Scientific Advisory Board appointed by UNC-CH to oversee the Research, requires a deviation from the Protocol, then such standards will be followed. In such case, the party aware of the need for a deviation will immediately inform the other of the facts causing such deviation as soon as the facts are known to the party. If the aggregate amount of the costs of any and all required changes and/or deviations arising pursuant to clauses (b) or (c) of this Article 20 during the term of this Agreement, for which additional funding is not provided to Immtech by either the Bill & Melinda Gates Foundation, UNC-CH or any third party, exceed $300,000▇▇▇,00▇, then Immtech ▇▇▇▇ ▇▇▇▇▇ch may terminate this Agreement upon thirty (30) days written notice to UNC-CH.

Appears in 1 contract

Sources: Clinical Research Subcontract (Immtech International Inc)