PURCHASER MATERIALS. 7.1 The Purchaser shall supply the Purchaser Materials to GSK in a timely manner [***] on a [***] basis. Purchased Clinical API and Maintained Excess Clinical API subsequently purchased by the Purchaser pursuant to Clause 2 shall be deemed to have been supplied in a timely manner if the Parties agree that such Purchaser Materials shall be left in GSK’s possession on consignment. 7.2 GSK will not (and will procure that the Nominated Manufacturer does not) use the Purchaser Materials for any purpose other than the Manufacture of New Clinical Products for the Purchaser under this Agreement (including for testing, quality and compliance purposes). 7.3 GSK shall not be liable for any failure to meet, or for any delay in meeting, any Firm Order for New Clinical Products if such failure is as a result of any failure by the Purchaser to supply, or delay by the Purchaser in supplying, in a timely manner sufficient quantities of Purchaser Materials that comply with all applicable requirements of Applicable Law, cGMP and the applicable Specifications and have sufficient unexpired shelf life to enable such Purchaser Materials to be the Manufacture of Products in accordance with the schedule of Deliveries of any New Clinical Products contemplated by the Forecast Schedule; except in the event that such failure is due to the failure of GSK to supply New Clinical API in a timely manner or that meets cGMP (having regard to the Lead Time agreed between the Parties in respect of such New Clinical API pursuant to Clause 2.2(A) and the time required for analytical testing and GSK’s release in accordance with (and to the extent required by) the Quality Agreement prior to Delivery of such New Clinical API). CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED. 7.4 Each consignment of Purchaser Materials will be accompanied by Certificate of Analysis relating to such Purchaser Materials signed by, as applicable: (A) GSK’s or its Affiliate’s Qualified Person in respect of Purchased Clinical API and/or Maintained Excess Clinical API subsequently purchased by the Purchaser pursuant to Clause 2; or (B) the Purchaser’s Qualified Person in respect of New Clinical API. 7.5 The Purchaser shall retain title to the Purchaser Materials at all times. From the time Purchaser Materials are delivered to GSK’s loading dock at the relevant Manufacturing Site to the time such Purchaser Materials are returned (or Product is delivered) to the Purchaser’s designated carrier at GSK’s loading dock, GSK shall bear the risk of loss of or damage to such Purchaser Materials arising from [***] and shall be responsible for compensating the Purchaser for the lost or damaged Purchaser Materials (up to an amount not exceeding the Actual Cost of such Purchaser Materials to the Purchaser). At all other times and in all other circumstances, the Purchaser and shall bear the risk of loss or destruction to the Purchaser Materials. 7.6 For the avoidance of doubt, GSK, or its Affiliate, has Manufactured (or, in the case of any New Clinical API, will Manufacture under this Agreement) all Purchaser Materials. 7.7 The Purchaser shall inform and keep GSK and the Nominated Manufacturer informed of all safety hazards and changes in regulations and guidance (statutory or otherwise) which the Purchaser or its Affiliate knows or believes affect or may affect the use, handling, storage, labelling, transport, treatment and disposal of any Purchaser Materials.
Appears in 2 contracts
Samples: Clinical Manufacturing and Supply Agreement (Roivant Sciences Ltd.), Clinical Manufacturing and Supply Agreement (Dermavant Sciences LTD)
PURCHASER MATERIALS. 7.1 8.1 The Purchaser shall supply the Purchaser Materials to GSK at the designated Manufacturing Site in respect of Commercial Product in a timely manner [***] on a [***] basis. Purchased Clinical API and Maintained Excess Clinical API subsequently purchased by the Purchaser pursuant to Clause 2 shall be deemed to have been supplied in a timely manner if the Parties agree that such Purchaser Materials shall be left in GSK’s possession on consignment].
7.2 8.2 GSK will not (and will procure that the Nominated Manufacturer does not) use the Purchaser Materials for any purpose other than the Manufacture of New Clinical Commercial Products for the Purchaser under this Agreement (including for testing, quality and compliance purposes).
7.3 8.3 GSK shall not be liable for any failure to meet, or for any delay in meeting, any Firm Order for New Clinical Commercial Products if such failure is as a result of any failure by the Purchaser to supply, or delay by the Purchaser in supplying, in a timely manner sufficient quantities of Purchaser Materials that comply with all applicable requirements of Applicable Law, cGMP and the applicable Specifications and have sufficient unexpired shelf life to enable such Purchaser Materials to be the Manufacture of Products in accordance with the schedule of Deliveries of any New Clinical Commercial Products contemplated by the Forecast Schedule; except in the event that such failure is due to the failure of GSK to supply New Clinical Commercial API in a timely manner or that meets cGMP (having regard to taking due account of the applicable Lead Time agreed between the Parties in respect of for such New Clinical API pursuant to Clause 2.2(A) and the time required for analytical testing and GSK’s release in accordance with (and to the extent required by) the Quality Agreement prior to Delivery of such New Clinical Commercial API). CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
7.4 8.4 Each consignment quantity of Purchaser Materials will be accompanied by Certificate of Analysis relating to such Purchaser Materials Materials, which, to the extent required by Applicable Law in the relevant jurisdiction, shall be signed by, as applicable:
(A) GSK’s or its Affiliate’s Qualified Person in respect of Purchased Clinical API and/or Maintained Excess Clinical API subsequently purchased by the Purchaser pursuant to Clause 2; or
(B) the Purchaser’s Qualified Person in respect of New Clinical Commercial API.
7.5 8.5 The Purchaser shall retain title to the Purchaser Materials at all times. From the time Purchaser Materials are delivered to GSK’s loading dock at the relevant Manufacturing Site to the time such Purchaser Materials are returned (or Product is delivered) to the Purchaser’s designated carrier at GSK’s loading dock, GSK shall bear the risk of loss of or damage to such Purchaser Materials arising from GSK’s [***] and shall be responsible for compensating the Purchaser for the lost or damaged Purchaser Materials (up to an amount not exceeding the Actual Cost of such Purchaser Materials to the Purchaser). At all other times and in all other circumstances, the Purchaser and shall bear the risk of loss or destruction to the Purchaser Materials.
7.6 For the avoidance of doubt, GSK, or its Affiliate, has Manufactured (or, in the case of any New Clinical API, will Manufacture under this Agreement) all Purchaser Materials.
7.7 8.6 The Purchaser shall inform and keep GSK and the Nominated Manufacturer informed of all safety hazards and changes in regulations and guidance (statutory or otherwise) which the Purchaser or its Affiliate knows or believes affect or may affect the use, handling, storage, labelling, transport, treatment and disposal of any Purchaser Materials.
Appears in 2 contracts
Samples: Commercial Manufacturing and Supply Agreement (Roivant Sciences Ltd.), Commercial Manufacturing and Supply Agreement (Dermavant Sciences LTD)
PURCHASER MATERIALS. 7.1 The Purchaser shall supply the Purchaser Materials to GSK in a timely manner [***] on a [***] basis. Purchased Clinical API and Maintained Excess Clinical API subsequently purchased by the Purchaser pursuant to Clause 2 shall be deemed to have been supplied in a timely manner if the Parties agree that such Purchaser Materials shall be left in GSK’s possession on consignment.
7.2 GSK will not (and will procure that the Nominated Manufacturer does not) use the Purchaser Materials for any purpose other than the Manufacture of New Clinical Products for the Purchaser under this Agreement (including for testing, quality and compliance purposes).
7.3 GSK shall not be liable for any failure to meet, or for any delay in meeting, any Firm Order for New Clinical Products if such failure is as a result of any failure by the Purchaser to supply, or delay by the Purchaser in supplying, in a timely manner sufficient quantities of Purchaser Materials that comply with all applicable requirements of Applicable Law, cGMP and the applicable Specifications and have sufficient unexpired shelf life to enable such Purchaser Materials to be the Manufacture of Products in accordance with the schedule of Deliveries of any New Clinical Products contemplated by the Forecast Schedule; except in the event that such failure is due to the failure of GSK to supply New Clinical API in a timely manner or that meets cGMP (having regard to the Lead Time agreed between the Parties in respect of such New Clinical API pursuant to Clause 2.2(A) and the time required for analytical testing and GSK’s release in accordance with (and to the extent required by) the Quality Agreement prior to Delivery of such New Clinical API). [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***]BRACKETS, HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED IS FILED WITH THE INFORMATION (I) IS NOT MATERIAL SECURITIES AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM EXCHANGE COMMISSION PURSUANT TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSEDRULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
7.4 Each consignment of Purchaser Materials will be accompanied by Certificate of Analysis relating to such Purchaser Materials signed by, as applicable:
(A) GSK’s or its Affiliate’s Qualified Person in respect of Purchased Clinical API and/or Maintained Excess Clinical API subsequently purchased by the Purchaser pursuant to Clause 2; or
(B) the Purchaser’s Qualified Person in respect of New Clinical API.
7.5 The Purchaser shall retain title to the Purchaser Materials at all times. From the time Purchaser Materials are delivered to GSK’s loading dock at the relevant Manufacturing Site to the time such Purchaser Materials are returned (or Product is delivered) to the Purchaser’s designated carrier at GSK’s loading dock, GSK shall bear the risk of loss of or damage to such Purchaser Materials arising from [***] and shall be responsible for compensating the Purchaser for the lost or damaged Purchaser Materials (up to an amount not exceeding the Actual Cost of such Purchaser Materials to the Purchaser). At all other times and in all other circumstances, the Purchaser and shall bear the risk of loss or destruction to the Purchaser Materials.
7.6 For the avoidance of doubt, GSK, or its Affiliate, has Manufactured (or, in the case of any New Clinical API, will Manufacture under this Agreement) all Purchaser Materials.
7.7 The Purchaser shall inform and keep GSK and the Nominated Manufacturer informed of all safety hazards and changes in regulations and guidance (statutory or otherwise) which the Purchaser or its Affiliate knows or believes affect or may affect the use, handling, storage, labelling, transport, treatment and disposal of any Purchaser Materials.
Appears in 1 contract
Samples: Clinical Manufacturing and Supply Agreement (Dermavant Sciences LTD)
PURCHASER MATERIALS. 7.1 The [*] Purchaser and/or its agents or subcontractors shall provide Supplier with Purchaser Materials meeting the [*] Specifications as necessary for the manufacture of Supply Deliverables. Supplier shall maintain a reasonable supply of Purchaser Materials in good condition as required to permit Supplier to satisfy its obligations hereunder and shall notify Purchaser at least [*] days prior to the date on which additional Purchaser Materials are required to satisfy orders hereunder. Purchaser shall supply the deliver or cause to be delivered to Supplier such quantities of Purchaser Materials as are specified in such notice no later than the date so required. Supplier shall maintain records with respect to GSK in a timely manner [***] on a [***] basis. Purchased Clinical API the amount, location and Maintained Excess Clinical API subsequently purchased by the Purchaser pursuant to Clause 2 shall be deemed to have been supplied in a timely manner if the Parties agree that such usage of Purchaser Materials supplied by Purchaser and make such records available to Purchaser upon request. Supplier shall be left in GSK’s possession on consignment.
7.2 GSK will not (and will procure that the Nominated Manufacturer does not) use the Purchaser Materials for any purpose other than the Manufacture of New Clinical Products solely for the purpose of manufacturing Supply Deliverables for Purchaser. Supplier shall promptly notify Purchaser if any Purchaser Materials delivered hereunder fail to comply with the [*] Specifications and shall at Purchaser’s request immediately make such Purchaser Materials available to a carrier selected by Purchaser for return to Purchaser at Purchaser’s expense. Any Purchaser Materials that fail to comply with the [*] Specifications shall be replaced by Purchaser as soon as reasonably practicable and in no event later than [*] days after receipt of notice from Supplier. If, despite Supplier’s satisfaction of its obligations under this Agreement (including for testingSection, quality and compliance purposes).
7.3 GSK shall not be liable for any failure Purchaser fails to meet, or for any delay in meeting, any Firm Order for New Clinical Products if such failure is as a result of any failure by the Purchaser timely deliver to supply, or delay by the Purchaser in supplying, in a timely manner sufficient quantities of Supplier Purchaser Materials that comply with all applicable requirements of Applicable Lawthe [*] Specifications, cGMP and the applicable Specifications and have sufficient unexpired shelf life Supplier’s obligation to enable such Purchaser Materials to be the Manufacture of Products in accordance with the schedule of Deliveries of any New Clinical Products contemplated deliver Supply Deliverables by the Forecast Schedule; except date specified in the event that such failure is due to the failure of GSK to supply New Clinical API in a timely manner or that meets cGMP (having regard to the Lead Time agreed between the Parties in respect of such New Clinical API pursuant to Clause 2.2(A) and the time required for analytical testing and GSK’s release in accordance with (and an order hereunder shall be tolled to the extent required by) the Quality Agreement prior such delivery of Supply Deliverables cannot be made due to Delivery of such New Clinical API). CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE DERMAVANT SCIENCES LTD. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO DERMAVANT SCIENCES LTD. IF PUBLICLY DISCLOSED.
7.4 Each consignment shortage of Purchaser Materials Materials. Supplier will be accompanied by Certificate take no action that could result in a lien on or other encumbrance of, or that could otherwise compromise Purchaser’s ownership of, Purchaser Materials. Upon the termination or expiration of Analysis relating this Agreement, Supplier will return to such Purchaser in good condition all Purchaser Materials signed by, as applicable:
(A) GSK’s or its Affiliate’s Qualified Person in respect of Purchased Clinical API and/or Maintained Excess Clinical API subsequently purchased by the not incorporated into Supply Deliverables supplied to Purchaser pursuant to Clause 2; or
(B) the Purchaser’s Qualified Person in respect of New Clinical APIhereunder.
7.5 The Purchaser shall retain title to the Purchaser Materials at all times. From the time Purchaser Materials are delivered to GSK’s loading dock at the relevant Manufacturing Site to the time such Purchaser Materials are returned (or Product is delivered) to the Purchaser’s designated carrier at GSK’s loading dock, GSK shall bear the risk of loss of or damage to such Purchaser Materials arising from [***] and shall be responsible for compensating the Purchaser for the lost or damaged Purchaser Materials (up to an amount not exceeding the Actual Cost of such Purchaser Materials to the Purchaser). At all other times and in all other circumstances, the Purchaser and shall bear the risk of loss or destruction to the Purchaser Materials.
7.6 For the avoidance of doubt, GSK, or its Affiliate, has Manufactured (or, in the case of any New Clinical API, will Manufacture under this Agreement) all Purchaser Materials.
7.7 The Purchaser shall inform and keep GSK and the Nominated Manufacturer informed of all safety hazards and changes in regulations and guidance (statutory or otherwise) which the Purchaser or its Affiliate knows or believes affect or may affect the use, handling, storage, labelling, transport, treatment and disposal of any Purchaser Materials.
Appears in 1 contract
Samples: Supply Agreement (Cardiomems Inc)