Common use of Required Changes Clause in Contracts

Required Changes. ActaMed shall be required to develop and implement, at its expense except to the extent hereinafter provided, as promptly as practicable and in no event later than thirty (30) days prior to the effective date of the applicable Regulatory Change, any Changes which (i) ActaMed determines are required for the Network Software to remain in compliance with all applicable Regulations, or (ii) SBCL requests in writing to ActaMed for compliance with Regulations of the Network Software. 1. If SBCL reasonably determines that ActaMed cannot provide such required work by thirty (30) days prior to a deadline imposed by governmental authority, SBCL shall have the [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. right to contract with a third party for such work or to do such work itself. In such event, SBCL shall be reimbursed therefor by ActaMed, except as provided in Section V.C.3 below. 2. Upon reasonable advance written notice to ActaMed, SBCL may request, and if it so requests ActaMed shall use its good faith efforts to accommodate, prioritization of such Changes over any other software development work performed by or on behalf of ActaMed. 3. In any event, upon reasonable advance notice to ActaMed, SBCL shall be entitled to change the prioritization of required Changes from time to time and to resolve conflicts between Changes demanding equal prioritization to the extent necessary to deliver any such Change not less than thirty (30) days prior to any government imposed deadlines or as promptly as practicable. 4. If ActaMed disputes that Changes requested by SBCL pursuant to clause (ii) of Section V.C are required by Regulations, either ActaMed or SBCL shall be entitled to cause the dispute to be resolved in accordance with the procedures set forth in Section XV.B.1.a and XV.B.1.b thereof. If such process is used and results in substantial agreement with either (i) ActaMed, then [*] (including the cost of FTEs) in implementing such Changes, or (ii) SBCL, [*]. If such process is not used or does not result in an agreement as to whether or not such Change is required by Regulations, ActaMed and SBCL shall mutually agree on an outside counsel familiar with issues of the nature involved in the dispute and the opinion of such counsel shall be binding on the parties hereto.

Required Changes. ActaMed OptiNose shall be required deliver to develop and implement, at its expense except Hovione written notice of any changes to the extent hereinafter providedProduct Specifications requested by OptiNose or required by the FDA, PMDA, or EMA, and Hovione shall use its [***] to timely make such conforming changes to the Product Specifications in accordance with Applicable Laws and the requirements of this Agreement. If any change to Product Specifications requested by OptiNose [***], then Hovione shall promptly so inform OptiNose in writing and the Parties shall negotiate, in good faith, an adjustment to the pricing paid by OptiNose for API under this Agreement. (a) In the case of required changes by the FDA, PMDA or EMA, Hovione shall deliver to OptiNose a good faith and detailed estimate of the increase in Hovione’s cost to manufacture the API as a result of the required change. If the parties cannot agree to the applicable price adjustment resulting from such required changed, OptiNose may require Hovione to make the required change to the Specifications and/or process while the Parties continue negotiations in good faith as to the costs associated with such change, which shall not delay Hovione’s obligations to, as soon as reasonably practicable, implement such changes, in which case, OptiNose shall pay the price requested by Hovione for such API; provided further, that Hovione shall promptly as practicable refund any overpayment by OptiNose should the price later be contradicted by the third-party audit specified in Section 4.5(b). Additionally, if the required change impacts any API already ordered by a Firm Forecast pursuant to Section 3.2, OptiNose shall cover any increased costs that impact such already ordered API, while the parties thereafter discuss in good faith pursuant to this Section 4.5 whether such increase was confirmed or contradicted by the auditor. (b) OptiNose shall reserve the right to a third-party audit of the increased cost contributions with auditors reasonably agreeable to both parties, who shall communicate simultaneously to both parties hereto if the estimate amount is confirmed or contradicted. If contradicted, Hovione agrees to make all applicable changes to API required by the FDA and supply same to OptiNose at the price stated by the auditor for the duration of the Term of the Agreement. If the increase is confirmed, but OptiNose does not agree to pay such increase in no event later than thirty (30) days prior transfer price, or if the parties cannot otherwise agree on an equitable adjustment to the effective date of the applicable Regulatory Changetransfer price, any Changes which (i) ActaMed determines are required for the Network Software to remain in compliance with all applicable Regulations, or (ii) SBCL requests in writing to ActaMed for compliance with Regulations of the Network Software. 1. If SBCL reasonably determines that ActaMed cannot provide such required work by thirty (30) days prior to a deadline imposed by governmental authority, SBCL shall have the then either party may terminate this Agreement upon [***] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. right to contract with a third party for such work or to do such work itself. In such event, SBCL shall be reimbursed therefor by ActaMed, except as provided in Section V.C.3 below. 2. Upon reasonable ([***]) months advance written notice to ActaMed, SBCL may request, and if it so requests ActaMed shall use its good faith efforts to accommodate, prioritization of such Changes over any the other software development work performed by or on behalf of ActaMed. 3party. In any eventsuch case, upon reasonable advance notice to ActaMed, SBCL the Agreement shall be entitled to change continue in force at the prioritization of required Changes from time to time and to resolve conflicts between Changes demanding equal prioritization to price stated by the extent necessary to deliver any such Change not less than thirty (30) days prior to any government imposed deadlines or as promptly as practicable. 4. If ActaMed disputes that Changes requested by SBCL pursuant to clause (ii) of Section V.C are required by Regulations, either ActaMed or SBCL shall be entitled to cause the dispute to be resolved in accordance with the procedures set forth in Section XV.B.1.a and XV.B.1.b thereof. If such process is used and results in substantial agreement with either (i) ActaMed, then auditor for said [***] (including the cost [***]) month period in order to provide OptiNose with an opportunity, in its discretion, to arrange for transition to an alternate supplier of FTEs) in implementing such Changes, or (ii) SBCLits choosing, [***]. If During such process is period Hovione shall continue to supply OptiNose with API and OptiNose shall continue purchasing API from Hovione as per the FDA required changed Product Specification and OptiNose must take delivery of all products for which firm orders have been placed. (c) In the case of required changes by either Party not used or does requested by regulatory action, if the parties cannot result in an agreement as to whether or not such Change is required by Regulations, ActaMed and SBCL shall mutually agree on an outside counsel familiar equitable adjustment to the pricing the Agreement may be terminated provided [***] ([***]) months written notice. During such period Hovione shall continue to supply OptiNose with issues API and OptiNose shall continue purchasing API from Hovione as per the previously agreed Product Specification and OptiNose must take delivery of all product for which firm orders have been placed (d) In the nature involved case where a disagreement between the parties to a price change pursuant to this Section 4.5 causes a delay in the dispute and the opinion of delivery by Hovione, such counsel delay shall be binding on excused; provided [***] the parties heretoseparately continue discussions regarding such increased costs.

Required Changes. ActaMed shall be required to develop and implement, at its expense except to the extent hereinafter provided, as promptly as practicable and in no event later than thirty (30) days prior to the effective date of the applicable Regulatory Change, any Changes which (i) ActaMed determines are required for the Network Software to remain in compliance with all applicable Regulations, or (ii) SBCL requests in writing to ActaMed for compliance with Regulations of the Network Software. 1. If SBCL reasonably determines that ActaMed cannot provide such required work by thirty (30) days prior to a deadline imposed by governmental authority, SBCL shall have the [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. right to contract with a third party for such work or to do such work itself. In such event, SBCL shall be reimbursed therefor by ActaMed, except as provided in Section V.C.3 below. 2. Upon reasonable advance written notice to ActaMed, SBCL may request, and if it so requests ActaMed shall use its good faith efforts to accommodate, prioritization of such Changes over any other software development work performed by or on behalf of ActaMed. 3. In any event, upon reasonable advance notice to ActaMed, SBCL shall be entitled to change the prioritization of required Changes from time to time and to resolve conflicts between Changes demanding equal prioritization to the extent necessary to deliver any such Change not less than thirty (30) days prior to any government imposed deadlines or as promptly as practicable. 4. If ActaMed disputes that Changes requested by SBCL pursuant to clause (ii) of Section V.C are required by Regulations, either ActaMed or SBCL shall be entitled to cause the dispute to be resolved in accordance with the procedures set forth in Section XV.B.1.a and XV.B.1.b thereof. If such process is used and results in substantial agreement with either (i) ActaMed, then [*] (including the cost of FTEs) in implementing such Changes, or (ii) SBCL, [*]. If such process is not used or does not result in an agreement as to whether or not such Change is required by Regulations, ActaMed and SBCL shall mutually agree on an outside counsel familiar with issues of the nature involved in the dispute and the opinion of such counsel shall be binding on the parties hereto.

Required Changes. ActaMed The following changes shall be required to develop and implement, at its expense except to the extent hereinafter provided, as promptly as practicable and in no event later than thirty (30) days prior to the effective date of the applicable Regulatory Change, any Changes which constitute Required Changes: (i) ActaMed determines changes to the Specifications or Manufacturing or Packaging processes that are required for the Network Software to remain in compliance with all applicable Regulationsby laws or regulations (including, without limitation, cGMP), or by medical or scientific concerns as to the quality, safety and/or efficacy of the Product (collectively "Required Changes"); (ii) SBCL requests in writing changes to ActaMed for compliance with Regulations the Specifications or Manufacturing or Packaging processes which arise out of the Network Software. 1. If SBCL reasonably determines that ActaMed cannot provide such required work by thirty (30) days prior change of Manufacturer from XXX to a deadline imposed by governmental authority, SBCL shall have the [*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. right to contract with a third party for such work or to do such work itself. In such event, SBCL shall be reimbursed therefor by ActaMed, except as provided in Section V.C.3 below. 27.8; and (iii) changes which XXX reasonably considers necessary or desirable and which do not change the character or identity of the Product in such a way as to have an adverse effect on Pharmion's interest in the Product in the Territory. Upon reasonable advance written notice to ActaMedThe Parties shall cooperate in making such Required Changes promptly. If a Required Change is necessary because of laws or regulations that apply in the Territory but not in the XXX Territory, SBCL may request, and if it so requests ActaMed shall use its good faith efforts to accommodate, prioritization all costs of making such Changes over any other software development work performed by or on behalf of ActaMed. 3. In any event, upon reasonable advance notice to ActaMed, SBCL Required Change shall be entitled to change borne by Pharmion. Conversely, if a Required Change is necessary because of laws or regulations that apply in the prioritization XXX Territory but not in the Territory, all reasonable costs of required Changes from time to time and to resolve conflicts between Changes demanding equal prioritization to the extent necessary to deliver any making such Required Change not less than thirty (30) days prior to any government imposed deadlines or as promptly as practicable. 4shall be borne by XXX. If ActaMed disputes that Changes requested by SBCL pursuant to clause (ii) of Section V.C are required by Regulations, either ActaMed or SBCL shall be entitled to cause the dispute to be resolved in accordance with the procedures set forth in Section XV.B.1.a and XV.B.1.b thereof. If such process is used and results in substantial agreement with either (i) ActaMed, then [*] (including the cost of FTEs) in implementing such Changes, or (ii) SBCL, [*]. If such process is not used or does not result in an agreement as to whether or not such a Required Change is required by Regulationsthe FDA and Agencies in both the Territory and the XXX Territory, ActaMed then XXX and SBCL Pharmion shall mutually agree on share the reasonable cost of such Required Change in proportion to their respective Sharing Percentages. If: (i) an outside counsel familiar with issues FDA request disables the implementation of requirements of an Agency in the XXX Territory, (ii) an Agency request disables the implementation of requirements of the nature involved FDA or the FDA does not approve of a change required by an Agency, or (iii) despite the exercise of Commercially Reasonable Efforts, XXX is unable to make or have a Required Change of the FDA made without material adverse effects on the Product in the dispute XXX Territory, then the Parties will negotiate in good faith to solve this issue and the opinion of make such counsel shall be binding on the parties heretoadjustments to this Agreement as are fair and equitable.