Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 12 contracts
Samples: Manufacturing Services Agreement (Acelrx Pharmaceuticals Inc), Product Agreement (Osmotica Pharmaceuticals PLC), Product Agreement (Osmotica Pharmaceuticals LTD)
Timing. The expert will shall be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the such authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days (or another such other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph pursuant to paragraph 4(b) hereof.
Appears in 9 contracts
Samples: Manufacturing Services Agreement, Manufacturing Services Agreement (Reliant Pharmaceuticals, Inc.), Manufacturing Services Agreement (Cephalon Inc)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 5 contracts
Samples: Master Manufacturing Services Agreement (Indivior PLC), Master Manufacturing Services Agreement (Indivior PLC), Master Manufacturing Services Agreement
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days [***] (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 4 contracts
Samples: Services Agreement (Evoke Pharma Inc), Services Agreement (Evoke Pharma Inc), Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 [*] Business Days (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 3 contracts
Samples: Product Agreement (Jazz Pharmaceuticals PLC), Services Agreement, Product Agreement (Jazz Pharmaceuticals PLC)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties Parties and that he issues the authorizations to the parties Parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 […***…] Business Days (or another other date as the parties Parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 3 contracts
Samples: Product Agreement (Acadia Pharmaceuticals Inc), Product Agreement (Acadia Pharmaceuticals Inc), Product Agreement (Acadia Pharmaceuticals Inc)
Timing. The expert will be so appointed on condition that (i) he or she promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties Parties and that she or he issues the authorizations instructions to the parties Parties and any relevant third party Third Party for the proper conduct of his or her determination and any hearing and (ii) he the expert renders his or her decision (with full reasons) within 15 Business Days business days (or another other date as the parties and the expert may agree) after receipt of all information requested by her or him under Paragraph 4(b) hereof.
Appears in 2 contracts
Samples: Supply Agreement (Relypsa Inc), Supply Agreement (Relypsa Inc)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 [**] Business Days (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 2 contracts
Samples: Product Agreement (La Jolla Pharmaceutical Co), Product Agreement (Tetraphase Pharmaceuticals Inc)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 […***…] Business Days (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 2 contracts
Samples: Product Agreement (Horizon Pharma, Inc.), Product Agreement (Horizon Pharma, Inc.)
Timing. The expert will shall be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the such authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 [**] Business Days (or another such other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph pursuant to paragraph 4(b) hereof.
Appears in 2 contracts
Samples: Quality Agreement (Sepracor Inc /De/), Quality Agreement (Sepracor Inc /De/)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days […***…] (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Horizon Pharma PLC), Manufacturing Services Agreement (Horizon Pharma PLC)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties Parties and that he issues the authorizations to the parties Parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days [* * *] (or another other date as the parties Parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 2 contracts
Samples: Product Agreement (Paratek Pharmaceuticals, Inc.), Product Agreement (Paratek Pharmaceuticals, Inc.)
Timing. The expert will shall be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the such authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days (or another such other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph pursuant to paragraph 4(b) hereof.. (b)
Appears in 1 contract
Samples: Manufacturing Services Agreement
Timing. The expert will be so appointed on condition that (i) he or she promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties Parties and that he or she issues the authorizations to the parties Parties and any relevant third party Third Party for the proper conduct of his or her determination and any hearing and (ii) he or she renders his decision (with full reasons) within 15 [**] Business Days (or another other date as the parties Parties and the expert may agree) after receipt of all information requested by him or her under Paragraph 4(b) hereof.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Penwest Pharmaceuticals Co)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 [***] Business Days (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 1 contract
Samples: Product Agreement (Horizon Therapeutics Public LTD Co)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 [**] Business Days (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Nabriva Therapeutics PLC)
Timing. The expert will shall be so appointed on condition that (i) he the expert promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the such authorizations to the parties and any relevant third party Third Party for the proper conduct of his a determination and any hearing and (ii) he the expert renders his a decision (with full reasons) within 15 fifteen (15) Business Days (or another such other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph the expert pursuant to paragraph 4(b) hereof.
Appears in 1 contract
Samples: Quality Agreement (Depomed Inc)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 [***] Business Days (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 1 contract
Timing. The expert will shall be so appointed on condition that (i) he the expert promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the such authorizations to the parties and any relevant third party Third Party for the proper conduct of his a determination and any hearing and (ii) he the expert renders his a decision (with full reasons) within 15 Business Days [*****] (or another such other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph the expert pursuant to paragraph 4(b) hereof.
Appears in 1 contract
Samples: Drug Product Manufacturing Services Agreement (Egalet Corp)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties Parties and that he issues the authorizations to the parties Parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days (or another other date as the parties Parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 1 contract
Samples: Commercial Supply Agreement (Supernus Pharmaceuticals Inc)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 […***…] Business Days (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 1 contract
Timing. The expert will shall be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the such authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days (or another such other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(bpursuant to paragraph 3(b) hereof.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Somaxon Pharmaceuticals, Inc.)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties Parties and that he issues the authorizations to the parties Parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 fifteen (15) Business Days (or another other date as the parties Parties and the expert may agree) after receipt of all information requested by him under Paragraph paragraph 4(b) hereof.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Keryx Biopharmaceuticals Inc)
Timing. The expert will shall be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the such authorizations to the parties and any relevant third party Third Party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days (or another such other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph pursuant to paragraph 4(b) hereof.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Avanir Pharmaceuticals)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b3(b) hereof.
Appears in 1 contract
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 Business Days [*****] (or another other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Raptor Pharmaceutical Corp)
Timing. The expert will be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties Parties and that he issues the authorizations to the parties Parties and any relevant third party Third Party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 [***] Business Days (or another other date as the parties Parties and the expert may agree) after receipt of all information requested by him under Paragraph 4(b) hereof.
Appears in 1 contract
Samples: Manufacturing and Supply Agreement (ChemoCentryx, Inc.)
Timing. The expert will shall be so appointed on condition that (i) he promptly fixes a reasonable time and place for receiving representations, submissions or information from the parties and that he issues the such authorizations to the parties and any relevant third party for the proper conduct of his determination and any hearing and (ii) he renders his decision (with full reasons) within 15 forty-five (45) Business Days (or another such other date as the parties and the expert may agree) after receipt of all information requested by him under Paragraph pursuant to paragraph 4(b) hereof.
Appears in 1 contract