Product Labeling. (a) Hospira shall label the Product in accordance with the Product Specifications using content provided by Theravance. Theravance shall control the content and type of all labeling and packaging (and any changes or supplements thereto) for the Product and shall have the responsibility, at Theravance’s expense, for: (i) ensuring such content is compliant with Regulatory Approval and all Applicable Law; and (ii) any changes or supplements to such content, including the expense of securing any approvals required by any applicable Regulatory Authority for any such changes or supplements. Hospira shall be responsible for obtaining such labels (and any changes or supplements thereto) in accordance with content specified by Theravance. (b) Any changes to the labeling and packaging shall be communicated to Hospira in writing at least [***] days prior to the desired implementation date together with the required documentation specifying the content to be included in the labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). Theravance shall reimburse Hospira for Hospira’s actual costs of making any changes under this Section 5.7(b) and for the cost of any labeling that Hospira is unable to use due to such changes.
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Samples: Technology Transfer and Supply Agreement (Theravance Biopharma, Inc.), Technology Transfer and Supply Agreement (Theravance Biopharma, Inc.), Technology Transfer and Supply Agreement (Theravance Inc)
Product Labeling. (a) Hospira shall label the Product in accordance with the Product Specifications using content provided by TheravanceOBI. Theravance OBI shall control the content and type of all labeling and packaging (and any changes or supplements thereto) for the Product and shall have the responsibility, at TheravanceOBI’s expense, for: (i) ensuring such content is compliant with Regulatory Approval regulatory approvals and all Applicable LawLaws; and (ii) any changes or supplements to such content, including the expense of securing any approvals required by any applicable Regulatory Authority for any such changes or supplements. Hospira shall be responsible for obtaining such labels (and any changes or supplements thereto) in accordance with the content specified by Theravance.OBI . Hospira – Oxygen Biotherapeutics Agreement
(b) Any changes to the labeling and packaging shall be communicated to Hospira in writing at least [***] seventy-five (75) days prior to the desired implementation date together with the required documentation specifying the content to be included in the labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). Theravance OBI shall reimburse Hospira for Hospira’s actual costs of making any changes under this Section 5.7(b) and for the cost of any labeling that Hospira is unable to use due to such changes.
Appears in 1 contract
Samples: Development and Supply Agreement (Oxygen Biotherapeutics, Inc.)
Product Labeling. (a) Hospira shall label the Product in accordance with the Product Specifications using content provided by TheravanceRevance. Theravance Revance shall control the content and type of all labeling and packaging (and any changes or supplements thereto) for the Product and shall have the responsibility, at TheravanceRevance’s expense, for: (i) ensuring such content is compliant with Regulatory Approval regulatory approvals and all Applicable Law; and (ii) any changes or supplements to such content, including the expense of securing any approvals required by any applicable Regulatory Authority for any such changes or supplements. Hospira shall be responsible for obtaining such labels (and any changes or supplements thereto) in accordance with the content specified by TheravanceRevance.
(b) Any changes to the labeling and packaging shall be communicated to Hospira in writing at least [***] days prior to the desired implementation date together with the required documentation specifying the content to be included in the labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). Theravance Revance shall reimburse Hospira for Hospira’s actual pre-approved costs of making any changes under this Section 5.7(b4.6(b) and for the cost of any labeling that Hospira is unable to use due to such changes.
Appears in 1 contract
Samples: Development and Supply Agreement (Revance Therapeutics, Inc.)