Shelf Life. The supply of Product delivered by Alexza to BLS hereunder shall have a minimum Shelf Life at the time when the title to, ownership of, and risk of loss of, the Product is passed from Alexza to BLS in accordance with Section 3.10(b) of this Agreement (the “Transfer Time”) as follows: (a) With respect to any Units of commercial Product supplied by Alexza prior to the approval by a Regulatory Authority of [ * ] months Expiration Dating, the Parties shall discuss in good faith the minimum Shelf Life required; provided that Alexza shall not ship any commercial Product having a Shelf Life less than [ * ] months without the prior written consent of BLS. (b) Upon approval by a Regulatory Authority of Expiration Dating of [ * ] months, with respect to commercial supply of the Product (including samples of the Product) such Product shall have a minimum Shelf Life of not less than [ * ] months; provided that [ * ], BLS shall reasonably consider and may accept Product with a Shelf Life between [ * ] months and [ * ] months. (c) Upon approval by a Regulatory Authority of Expiration Dating of [ * ] months, with respect to commercial supply of the Product (including samples of the Product) such Product shall have a minimum Shelf Life of not less than [ * ] months; provided that [ * ], BLS shall reasonably consider and may accept Product with a Shelf Life between [ * ] months and [ * ] months. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (d) Clinical trial material shall have a Shelf Life as mutually agreed by the Parties. (e) If any Units of commercial Product with Expiration Dating of [ * ] months or less that are purchased by BLS are returned to BLS or not saleable, then BLS may return [ * ] percent ([ * ]%) of such Units of Product to Alexza, and Alexza shall, as promptly as possible, replace such returned Units of Product with Units of the Product with a minimum of [ * ] months Shelf Life without charge; provided that the maximum number of Units of the Product that BLS may return and Alexza is required to replace pursuant to this Section 3.15(e) shall not exceed [ * ] Units.
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Samples: Manufacture and Supply Agreement, Manufacture and Supply Agreement (Alexza Pharmaceuticals Inc.)
Shelf Life. The supply of Product delivered by Alexza to BLS hereunder shall have a minimum Shelf Life at the time when the title to, ownership of, and risk of loss of, the Product is passed from Alexza to BLS in accordance with Section 3.10(b) of this Agreement (the “Transfer Time”) as follows:
(a) With respect to any Units of commercial Product supplied Unless otherwise agreed by Alexza prior the Parties in writing and except as set forth in clauses (b) and (c) below, Q-Med shall deliver to the approval by Purchaser Ordered Products with the Restylane trademark, Restylane Fine Lines trademark and Perlane trademark with a remaining shelf life of not less than **** from the date of delivery to the Purchaser, provided, however, that in the event a Regulatory Authority Approval for the shelf life (a "REGULATORY SHELF LIFE") of [ any of Restylane(R), Restylane Fine Lines(TM) or Perlane(TM) Licensed Products is obtained which is **** ] months Expiration Datingor greater. Q-Med shall deliver to the Purchaser Restylane(R), Restylane Fine Lines(TM) or Perlane(TM) Ordered Products, as the Parties shall discuss in good faith case may be, with a remaining shelf life not less than the minimum Shelf Life requiredgreater of ****; provided that Alexza notwithstanding the foregoing, Q-Med shall not ship be obligated to deliver Ordered Products with a remaining shelf life that is inconsistent with any commercial Product having a Shelf Life less than [ * ] months without Regulatory Approval or the prior written consent of BLSthen-current shelf life in the Labeling applicable to such Licensed Product.
(b) Upon approval by Notwithstanding the foregoing, for the period commencing on the date hereof and ending when an Amended Medical Device License Approval for the improved Restylane Fine Lines(TM) with a Regulatory Authority of Expiration Dating of [ * ] months, with respect to commercial supply of the Product (including samples of the Product) such Product shall have a minimum Shelf Life of **** or greater has been received by Q-Med, Q-Med shall deliver and the Purchaser shall accept Restylane Fine Lines(TM) Ordered Products with a remaining shelf life of not less than [ * ] months****; provided that [ * ], BLS Q-Med shall reasonably consider and may accept Product with a Shelf Life between [ * ] months and [ * ] monthsuse its commercially reasonable efforts to obtain such Amended Medical Device License Approval.
(c) Upon approval by a Regulatory Authority of Expiration Dating of [ * ] months, Other than with respect to commercial supply of the Product Restylane(R), Restylane Fine Lines(TM) and Perlane(TM) as set forth in clauses (including samples of the Producta) such Product shall have a minimum Shelf Life of not less than [ * ] months; provided that [ * ]and (b) above, BLS shall reasonably consider and may accept Product with a Shelf Life between [ * ] months and [ * ] months. [ * ] = Certain confidential information contained unless otherwise agreed in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(d) Clinical trial material shall have a Shelf Life as mutually agreed writing by the Parties.
(e) If any Units of commercial Product with Expiration Dating of [ * ] months or less that are purchased by BLS are returned , Q-Med shall deliver to BLS or not saleable, then BLS may return [ * ] percent ([ * ]%) of such Units of Product to Alexza, and Alexza shall, as promptly as possible, replace such returned Units of Product with Units of the Product Purchaser Licensed Products with a minimum of [ * ] months Shelf Life without charge; provided that the maximum number of Units remaining shelf life of the Product that BLS may return and Alexza is required to replace pursuant to this Section 3.15(e) shall not exceed [ * ] Units.applicable ****
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Shelf Life. The supply Initiation of Product delivered by Alexza to BLS hereunder shall have Manufacture will not occur until there is a minimum Shelf Life at Firm Order. Upon delivery of the time when the title to, ownership of, and risk of loss ofDrug Product, the Product is passed from Alexza to BLS in accordance with Section 3.10(b) Drug Product’s residual shelf life shall not be less than [**] months. For purposes of this Agreement (Section 2.10(g), the “Transfer Time”) as follows:
(a) With respect to any Units Parties agree that the shelf life of commercial the Drug Product supplied by Alexza prior to shall begin on the approval by a Regulatory Authority date of [ * Initiation of Manufacture. If LTS has delivered Drug Product with residual shelf life of less than [**] months Expiration Datingmonths, the Parties shall discuss in good faith ways to minimize the minimum Shelf Life requiredpotential loss to both Parties, including but not limited to, determining if NuPathe could sell the NuPathe Patch with the lower residual shelf life of the Drug Product and an appropriate discount to the Supply Price; provided, however, that if agreement cannot be reached on terms acceptable to NuPathe in its reasonable discretion, NuPathe shall not be obligated to accept such Drug Product and, in addition to any other rights or remedies available to NuPathe hereunder, LTS shall replace such Drug Product as soon as is reasonably possible and shall bear the disposal and shipping costs of such rejected Drug Product. Notwithstanding the foregoing, any reduction of the shelf life caused by (i) a force majeure as defined in Section 12.14, (ii) a delay or defect in the API supplied by NuPathe, (iii) a delay by NuPathe in its final release of the Drug Product, provided that Alexza such delay is not caused by LTS’ failure to perform or satisfy its obligations under this Agreement, (iv) the unavailability of temperature-controlled containers for shipment to be supplied by NuPathe or (v) an OOS or action by a regulatory agency not caused by the actions or inactions of LTS, shall not ship any commercial Product having be considered a Shelf Life less than [ * ] months without the prior written consent violation of BLS.
(b) Upon approval by a Regulatory Authority of Expiration Dating of [ * ] months, with respect to commercial supply of the Product (including samples of the Product) such Product shall have a minimum Shelf Life of not less than [ * ] months; provided that [ * ], BLS shall reasonably consider and may accept Product with a Shelf Life between [ * ] months and [ * ] months.
(c) Upon approval by a Regulatory Authority of Expiration Dating of [ * ] months, with respect to commercial supply of the Product (including samples of the Product) such Product shall have a minimum Shelf Life of not less than [ * ] months; provided that [ * ], BLS shall reasonably consider and may accept Product with a Shelf Life between [ * ] months and [ * ] months. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
(d) Clinical trial material shall have a Shelf Life as mutually agreed by the Parties.
(e) If any Units of commercial Product with Expiration Dating of [ * ] months or less that are purchased by BLS are returned to BLS or not saleable, then BLS may return [ * ] percent ([ * ]%) of such Units of Product to Alexza, and Alexza shall, as promptly as possible, replace such returned Units of Product with Units of the Product with a minimum of [ * ] months Shelf Life without charge; provided that the maximum number of Units of the Product that BLS may return and Alexza is required to replace pursuant to LTS’s delivery obligations under this Section 3.15(e) shall not exceed [ * ] Units.2.10(g). For purposes of this
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Samples: Commercial Supply and License Agreement (Nupathe Inc.)