Supply Disruption; Alternate Manufacturing Site Sample Clauses

Supply Disruption; Alternate Manufacturing Site. (a) CIMA shall supply Alamo with the Product, Product samples and Product placebos in a timely manner in accordance with the complete orders and forecasts received by CIMA pursuant to Sections 5.1(b) and 5.4(a), respectively. In any consecutive six (6) month period, should CIMA fail to supply Alamo with substantially all of the Product, Product samples or Product placebos ordered for such period pursuant to Section 5.1(b), Alamo shall have the right to require CIMA to transfer the manufacture of the Product to another manufacturing facility designated by Alamo and approved by CIMA, such approval not to be unreasonably withheld, which manufacturing facility agrees to be bound by Section 9.4 hereof. CIMA will assume all costs of; take all actions and grant all rights with respect to CIMA Technology as shall be necessary to effect such transfer. No additional royalties shall be imposed on Alamo or any manufacturer as a result of any transfer under this Section 5.7. Should CIMA cure its failure to supply, CIMA shall have the right to resume the manufacture of the Product and Alamo and CIMA shall, at CIMA’s expense, transfer the manufacture of the Product back to CIMA, if needed, within a commercially reasonable amount of time and all rights granted under the sublicense shall terminate. (b) If at any time following the Launch, if a second manufacturing facility is needed and Alamo wishes to qualify such a second manufacturing facility, capable of supplying the Product in accordance with the terms of this Agreement, CIMA and Alamo shall, as soon as practicable following the date of Launch, qualify a manufacturing plant designated by Alamo as an alternate FDA approved manufacturing and packaging site for the Product. The costs of obtaining such approval shall be borne by Alamo.
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Supply Disruption; Alternate Manufacturing Site. (a) CIMA shall use its best efforts to supply [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] with the Products in a timely manner in accordance with the orders and forecasts received by CIMA pursuant to Sections 5.1(b) and 5.4(a), respectively. In any consecutive [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period, should CIMA fail to supply [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] with a Product ordered for such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period pursuant to Section 5.1(b) (other than for reason of Force Majeure), [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall have the right to require CIMA to transfer the manufacture of such Product(s) to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***]'s [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] facility or other designated [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] facility. Should CIMA cure its failure to supply any Product so transferred, CIMA shall have the right to resume the manufacture of such Product and [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] and CIMA shall transfer the manufacture of such Product back to CIMA within a commercially reasonable amount of time. (b) CIMA shall, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] establish a second manufacturing plant as an alternate FDA-approved manufacturing site for the Products however, the second manufacturing plant is not required to contain a bottling capability
Supply Disruption; Alternate Manufacturing Site. (1) CIMA shall use its best efforts to supply Schwxxx xxxh the Product in a timely manner in accordance with the orders and forecasts received by CIMA pursuant to Sections 5.1(b) and 5.4(a), respectively. In any consecutive 120 day period, should CIMA fail to supply Schwxxx xxxh any of the Product ordered for such 120 day period pursuant to Section 5.1(b), Schwxxx xxxll have the right to require CIMA to transfer the manufacture of the Product to Schwxxx'x Xxxxxxx facility or other designated facility. CIMA will assume all costs of such transfer. Should CIMA cure its failure to supply, CIMA shall have the right to resume the manufacture of the Product and Schwxxx xxx CIMA shall, at CIMA's expense, transfer the manufacture of the Product back to CIMA within a commercially reasonable amount of time. (2) CIMA and Schwxxx xxxll, as soon as practicable following the date of Launch, qualify a manufacturing plant designated by Schwxxx xx an alternate FDA approved manufacturing and packaging site for the Product. The costs of obtaining such approval shall be borne equally by CIMA and Schwxxx.
Supply Disruption; Alternate Manufacturing Site. Nastech shall use its best efforts to supply Schwxxx xxxh Scopolamine Units in a timely manner in accordance with the orders and forecasts received by Nastech pursuant to Sections 4.1(b) and 4.5(a), respectively, such efforts to include the maintenance of a stock of the glass bottles and pumps from FDA approved vendors sufficient to produce 100% of the quantity of Scopolamine Units shipped to Schwxxx during the immediately preceding Quarter. In any Quarter, should Nastech fail to supply Schwxxx xxxh the greater of (x) 90% of the of the quantity of Scopolamine Units forecasted for such Quarter pursuant to Section 4.5(a) or (y) 90% of the quantity of Scopolamine Units shipped to Schwxxx xxxing the immediately preceding Quarter (if at least so many are ordered for such Quarter pursuant to Section 4.1(b)), Schwxxx xxxll have the right to manufacture Scopolamine Units and Schwxxx xxx Nastech shall transfer the manufacture of the Scopolamine Units to Schwxxx'x Xxxxxxx xxxility or other designated facility. Nastech will assume all costs of such transfer, such costs not to exceed $150,000. Should Nastech cure its failure to supply, Nastech shall have the right to resume the manufacture of Scopolamine Units and Schwxxx xxx Nastech shall, at Nastech's expense, transfer the manufacture of Scopolamine Units back to Nastech within a commercially reasonable amount of time.
Supply Disruption; Alternate Manufacturing Site. (a) CIMA shall use its best efforts to supply Xxxxxxx with the Products in a timely manner in accordance with the orders and forecasts received by CIMA pursuant to Sections 5.1(b) and 5.4(a), respectively. In any consecutive [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period, should CIMA fail to supply Xxxxxxx with a Product ordered for such [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] period pursuant to Section 5.1(b) (other than for reason of Force Majeure), Xxxxxxx shall have the right to require CIMA to transfer the manufacture of such Product(s) to Xxxxxxx'x Xxxxxxx facility or other designated Xxxxxxx facility. Should CIMA cure its failure to supply any Product so transferred, CIMA shall have the right to resume the manufacture of such Product and Xxxxxxx and CIMA shall transfer the manufacture of such Product back to CIMA within a commercially reasonable amount of time. (b) CIMA shall, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] establish a second manufacturing plant as an alternate FDA-approved manufacturing site for the Products however, the second manufacturing plant is not required to contain a bottling capability

Related to Supply Disruption; Alternate Manufacturing Site

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Product Specifications (a) Supplier shall manufacture all Products according to the Specifications in effect as of the date of this Agreement, with such changes or additions to the Specifications of the Products related thereto as shall be requested by Buyer in accordance with this Section or as otherwise agreed in writing by the Parties. All other Products shall be manufactured with such Specifications as the Parties shall agree in writing. (b) Buyer may request changed or additional Specifications for any Product by delivering written notice thereof to Supplier not less than one hundred twenty (120) days in advance of the first Firm Order for such Product to be supplied with such changed or additional Specifications. Notwithstanding the foregoing, if additional advance time would reasonably be required in order to implement the manufacturing processes for production of a Product with any changed or additional Specifications, and to commence manufacture and delivery thereof, Supplier shall so notify Buyer, and Supplier shall not be required to commence delivery of such Product until the passage of such additional time. (c) Supplier shall be required to accommodate any change of, or additions to, the Specifications for any Product, if and only if (i) in Supplier’s good faith judgment, such changed or additional Specifications would not require Supplier to violate good manufacturing practice, (ii) the representation and warranty of Buyer deemed made pursuant to Subsection (e) below is true and correct, and (iii) Buyer agrees to reimburse Supplier for the incremental costs and expenses incurred by Supplier in accommodating the changed or additional Specifications, including the costs of acquiring any new machinery and tooling. For the avoidance of doubt, such costs and expenses shall be payable by Buyer separately from the cost of Products at such time or times as Supplier shall request. (d) Supplier shall notify Buyer in writing within thirty (30) days of its receipt of any request for changed or additional Specifications (i) whether Supplier will honor such changed or additional Specifications, (ii) if Supplier declines to honor such changed or additional Specifications, the basis therefor and (iii) if applicable, the estimated costs and expenses that Buyer will be required to reimburse Supplier in respect of the requested changes or additions, as provided in Subsection (c) above. Buyer shall notify Supplier in writing within fifteen (15) days after receiving notice of any required reimbursement whether Buyer agrees to assume such reimbursement obligation. (e) By its request for any changed or additional Specifications for any Product, Buyer shall be deemed to represent and warrant to Supplier that the manufacture and sale of the Product incorporating Buyer’s changed or additional Specifications, as a result of such incorporation, will not and could not reasonably be expected to (i) violate or conflict with any contract, agreement, arrangement or understanding to which Buyer and/or any of its Affiliates is a party, including this Agreement and any other contract, agreement, arrangement or understanding with Supplier and/or its Affiliates, (ii) infringe on any trademark, service xxxx, copyright, patent, trade secret or other intellectual property rights of any Person, or (iii) violate any Applicable Law. Buyer shall indemnify and hold Supplier and its Affiliates harmless (including with respect to reasonable attorneys’ fees and disbursements) from any breach of this representation and warranty.

  • Bidder Supplied Samples The Commissioner reserves the right to request from the Bidder/Contractor a representative sample(s) of the Product offered at any time prior to or after award of a contract. Unless otherwise instructed, samples shall be furnished within the time specified in the request. Untimely submission of a sample may constitute grounds for rejection of Bid or cancellation of the Contract. Samples must be submitted free of charge and be accompanied by the Bidder’s name and address, any descriptive literature relating to the Product and a statement indicating how and where the sample is to be returned. Where applicable, samples must be properly labeled with the appropriate Bid or Contract reference. A sample may be held by the Commissioner during the entire term of the Contract and for a reasonable period thereafter for comparison with deliveries. At the conclusion of the holding period the sample, where feasible, will be returned as instructed by the Bidder, at the Bidder’s expense and risk. Where the Bidder has failed to fully instruct the Commissioner as to the return of the sample (i.e., mode and place of return, etc.) or refuses to bear the cost of its return, the sample shall become the sole property of the receiving entity at the conclusion of the holding period.

  • PRODUCT MANUFACTURER'S SUPPLIERS Only those dealers/distributors listed by the manufacturer will be considered authorized to act on behalf of the Product Manufacturer.

  • RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.

  • Alternate Work Schedule An alternate work schedule is any work schedule where an employee is regularly scheduled to work five (5) days per week, but the employee’s regularly scheduled two (2) days off are NOT Saturday and Sunday.

  • Packing Specifications 7.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

  • ODUF Packing Specifications 6.3.1 A pack will contain a minimum of one message record or a maximum of 99,999 message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of 99 packs and a minimum of one pack.

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

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