Kasan Insight :: 과학, 기술 그리고 법

- 제약/화학/바이오 분야의 실용적 법률정보와 해결방안

7. REGULATORY MATTERS.

7.1 Ownership of Product Regulatory Approvals and Documentation. Licensee shall own all Product Regulatory Approvals and Documentation in respect of each country in the Territory.

7.2 Conduct and Management of Regulatory Activities. Licensee will use its Commercially Reasonable Efforts:

(a) to maintain the First Approved NDA in the United States;

(b) to obtain Regulatory Approval for the Product for the Nocturia Indication in each other country in the Territory in accordance with the Development Plan;

and

(c) to obtain Regulatory Approval for the Product for the PNE Indication in each country in the Territory in accordance with the Development Plan.

Any breach by Licensee of its obligations under Section 7.2(a) shall be deemed to be a material breach of this Agreement for purposes of Article 14.

7.3 Transfer to Licensee of Product Regulatory Approvals and Documentation. Following the transfer to Licensee of ownership of the Product Regulatory Approvals and Documentation in each such country in the Territory pursuant to Section 2.3(b),

(a) Licensee or its designee shall be the owner of any and all Product Regulatory Approvals and Documentation in each such country in the Territory, subject to the Right of Reference or Use hereby granted by Licensee to Licensor in Section 2.5(c) for purposes of Development and Commercialization of Products outside the Territory;

(b) Except for the Development and Commercialization of Products by Licensor in the Territory pursuant to Section 6.3, Licensee shall have the responsibility, at its expense, for all regulatory activities (including, without limitation, Development Activities undertaken to support obtaining or maintaining Regulatory Approvals) and interactions relating to the Product in each country in the Territory, including without limitation preparing, obtaining, and maintaining Regulatory Approvals in each country in the Territory and all substantive interactions with such Regulatory Authorities relating thereto; and

(c) Licensee shall determine, in its sole discretion, the content of all such submissions and of all correspondence with Regulatory Authorities relating to the Product in the Territory.

(d) To the extent Licensor has not undertaken any Product Development Activities in the Territory under Section 2.5(c), Section 2.6, Section 6.1 and/or Article 14, Licensor hereby grants to Licensee a Right of Reference or Use in all Regulatory Approvals and Regulatory Documentation in respect of the Compound and any Products in respect of which Licensor is the sponsor for purposes of Licensee’s Development and Commercialization of Products in the Field and in the Territory. In consideration of such grant, Licensee will make one or more payments to Licensor determined in accordance with the same provisions set forth in clauses (ii) and (iii) in Section 2.5(c) in respect of Licensee’s grant of the Right of Reference or Use set forth in clause (i) of Section 2.5(c).

7.4 Regulatory Documentation for Generic Products.

(a) Each Party shall deliver written notice to the other Party of any notice it receives as to the submission, filing, or approval of an application, including, without limitation, an Abbreviated New Drug Application in the United States or the equivalent thereof in any other country in the Territory, in respect of a Generic Product within three (3) days after receipt or such notice thereof.

(b) Licensee shall have the sole right to respond to each such application, provided that Licensee shall consult with Licensor regarding any such application and the response thereto.

7.5 Audits. Licensor will have the continuing right during the Term of this Agreement, upon reasonable prior written notice to Licensee, to inspect, audit, and investigate any facilities, equipment, record-keeping procedures, and records utilized by Licensee and its subcontractors in connection with the Manufacture and Commercialization of the Product and any Development (including, without limitation, the conduct of Clinical Studies) of the Product.

7.6 Regulatory Authority Communications Received by a Party.

(a) Each Party shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection, or communication by or from any Person, including, without limitation, any Regulatory Authority in any country in the Territory, that may affect the safety or efficacy claims of the Product, have a material adverse effect on the Commercialization of the Product, or that otherwise suggests the Product may be in violation of Applicable Laws in such country.

(b) Upon receipt of such information described in Section 7.7(a), the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for Licensee to take at Licensee’s expense.

(c) Each Party shall keep the other Party informed, in a timely manner consistent with the reporting requirements of Regulatory Authorities, of notification of any action by any Regulatory Authority, or notification or other information that the Party receives (directly or indirectly) from any such Regulatory Authority, and provide to such other Party copies of all documents, if any, it received from such Regulatory Authority.

(d) Each Party will provide the other Party in a timely manner with a copy of all correspondence received from a Regulatory Authority specifically regarding the matters referred to in this Section 7.7.

7.7 Adverse Event Reporting and Safety Data Exchange.

(a) Licensee shall be responsible, at Licensee’s expense, in each country in the Territory for the monitoring of all clinical experiences, post-marketing experiences, and filing of all required reports with respect to the Product.

(b) Licensor shall transfer to Licensee the patient database, including without limitation the databases, in their entirety, containing pharmacokinetic, pharmacodynamic, efficacy, and safety information, developed in connection with the conduct of Clinical Studies for the Product under U.S. IND 076667, and all information relating thereto, in the format requested by Licensee. Licensor shall have the right to retain a copy of any and all such information transferred to Licensee.

(c) Each Party shall (i) notify the other Party immediately, but in no event later than three (3) Business Days, after becoming aware of any information concerning any complaint involving the possible failure of Product to meet any requirement of Applicable Laws, and any Unexpected Adverse Drug Experience or other serious or unexpected side effect, injury, toxicity, or sensitivity reaction or any unexpected incidents associated with the distribution or use of the Product and (ii) with respect to adverse events, comply with the provisions of this Section 7.7, and the applicable agreements described herein. Specific details regarding the exchange and management of information relating to adverse events related to the use of the Product shall be delineated and product labeling personnel of each Party shall work in good faith together during such time to negotiate an agreement that:

(i) identifies which safety information shall be exchanged, which shall include without limitation all adverse events for any Indication or condition;

(ii) identifies when such information shall be exchanged (which SAE information shall be provided within two (2) Business Days after notification of such SAE);

(iii) provides that Licensee shall (i) have regulatory reporting responsibilities, (ii) manage the global safety database, (iii) be obligated to obtain follow-up information on incomplete safety reports, (iv) review the literature for safety report information, and (v) prepare required periodic safety updates;

(iv) sets forth the roles and responsibilities of the Parties related to review and approval of safety information for inclusion in the Product labeling; provided that Licensee shall have the final decision-making authority with respect to any disputes regarding such activities with respect to Product in accordance with the terms and conditions hereof;

(v) identifies any other details required to appropriately manage safety information for the Product; and

(vi) as soon as reasonably practicable following the Effective Date, but in no event later than sixty (60) days thereafter Licensor and Licensee will agree upon the terms and conditions of the Pharmacovigilance Agreement and will thereupon execute and deliver to the other Party a copy of such Agreement.

7.8 Remedial Actions.

(a) Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains information indicating that the Product in the Field may be subject to a Remedial Action.

(b) The Parties will assist each other in gathering and evaluating such information as is required to determine the necessity of conducting a Remedial Action with respect to the Product in the Field in the Territory; provided, however, that Licensee shall have sole responsibility for collecting information from its customers in the Territory, including, without limitation, customer complaints, in accordance with the terms and conditions hereof.

(c) Each Party will maintain adequate records to permit the Parties to trace the manufacture of the Product in the Field and the distribution and use of the Product in the Field. In the event Licensee determines that any Remedial Action with respect to the Product in the Field in the Territory should be commenced or Remedial Action is required by any Governmental Authority having jurisdiction over the matter, Licensee will control and coordinate all efforts necessary to conduct such Remedial Action, provided that Licensee shall consult with Licensor or its designee regarding any such Remedial Action.

(d) The cost and expense of a Remedial Action (including the Parties’ reasonable costs and expenses in conducting such Remedial Action, but excluding claims described in Article 10) shall be allocated as follows:

(i) If such Remedial Action is due to Licensee’s gross negligence or willful misconduct, material breach of this Agreement, or material violation of or substantial noncompliance with any Law, but only to the extent such Remedial Action is due thereto, such costs and expenses shall be borne and paid by Licensee;

(ii) if and to the extent that such Remedial Action is due to Licensor’s gross negligence or willful misconduct, Licensor’s material breach of this Agreement, or Licensor’s material breach of or substantial noncompliance with any Law, but only to the extent such Remedial Action is due thereto, such costs and expenses shall be borne and paid by Licensor; and

(iii) if and to the extent that such Remedial Action is due to reasons other than as set forth in Sections 7.8(d)(i) and (ii), then: (A) Licensor shall bear and pay the costs and expenses incurred by the Parties in connection with a Remedial Action with respect to any lots of the Product subject to such Remedial Action that were manufactured by or for Licensor, as Licensor’s predecessor in interest; and (B) except for the Development and Commercialization of Product in the Territory by Licensor pursuant to Section 6.3, Licensee shall bear and pay the costs and expenses incurred by the Parties in connection with a Remedial Action with respect to any lots of the Product subject to such Remedial Action that were manufactured by or for Licensee and its contractors; provided, however, that nothing in this Section 7.8(d)(iii) is intended to limit or supersede any obligation that Renaissance may have in respect of any such lots of the Product subject to such Remedial Action.

KASAN_제약회사의 API 공급, 완제품 생산위탁, 완제품구매 계약서에서 정부의 제조품목허가 관련 계약조항 영문 샘플.pdf

미국 Cook Inc.과 Boston Scientific Corp.은 의료기기 stent 분야의 경쟁업체입니다. 양사는 1997년 stent에 항암제 paclitaxel을 코팅한 stent (paclitaxel-coated stent) 제품개발을 진행하였습니다. Angiotech사는 paclitaxel 특허권을 보유하고 있었습니다.

양사 모두 exclusive license를 체결하여, 각자 Exclusive right 보유한 licensee입니다. 공존의 의미로 co-exclusive로 표현하기도 합니다. 우리나라 특허법상 전용실시권 공유와 유사한 것으로 이해됩니다.

1. 분쟁대상 계약조항

Licensee Cook & Boston Scientific에 대한 GRANT 조항은 "use, manufacture, have manufactured, distribute and sell, and to grant sublicenses to its Affiliates to use, manufacture, have manufactured, distribute and sell, the Angiotech Technology ... for use in the Licensed Applications."입니다.

한편, "none of the parties could assign their rights or obligations under the agreement without the prior written consent of the other two."과 같은 명시적 제한 조항이 포함되어 있습니다.

2. Cook사의 계약위반 쟁점 행위

Cook사는 2001년 일방적으로 Advanced Cardiovascular Systems, Inc. ("ACS")와 다음과 같은 일련의 계약 5건을 체결하였습니다. (1) a Paclitaxel Coated Stent ("PCS") Distribution Agreement, (2) a Component Supply Agreement, (3) a PCS Development Agreement, (4) a Stent Delivery System Distribution Agreement, (5) a Cross-License Agreement

Cook사는 위 라이선스에서 허용한 판매행위는 최종 소비자에 대한 판매뿐만 아니라 판매를 사업으로 하는 도매상 등 중간상인에 대한 판매도 포함한다는 입장입니다. 판매범위에 특별한 제한을 둘 수 없다고 주장합니다.

허락된 생산행위도 직접 생산뿐만 아니라 제3자에게 대한 위탁생산도 포함된다는 입장입니다. 특히 계약 문언에 "have manufactured"도 포함되어 있습니다.

3. 계약위반 분쟁 및 쟁점

Cook과 Boston Scientific는 경쟁업체로 동일한 exclusive licensee이기 때문에 라이선스 계약범위에 관한 첨예하게 이해관계가 대립됩니다. Cook의 행위에 대해 Boston Scientific에서는 계약상 권리양도금지 조항을 위반하는 사실상 계약이전(de facto assignment)에 해당한다고 주장하였습니다.

반면, Cook사는 ACS는 Angiotech 특허기술에 대한 access도 없고 직접 권리를 획득하지도 않는다는 점을 강조하면서, Angiotech사와 라이선스 계약으로 허용된 권리행사에 불과하다고 주장합니다.

4. 미국법원 1,2심 판결 요지

미국법원은 Cook/ACS 계약을 “a transparent attempt to draft around the limitations clearly expressed within the Angiotech Agreement”로 보았습니다. 오직 Cook사와 Boston Scientific사만 라이선스 독점권의 공유자로서 Angiotech Technology 사용권을 갖는다는 범위제한을 내포하고 있다고 판시하였습니다.

양사에 독점권을 공동으로 부여한 계약에서 당사자들의 진정한 의사는 당사자 2개사 이외에 제3자 타사에 대한 위탁생산 또는 위탁판매를 예정하지 않았다고 보았습니다. 만약 그렇게 된다면 licensee 중 상대방에게 심대한 이해관계를 미치기 때문입니다.

제3자의 위수탁 생산, 판매행위는 계약문언상 포함된 것으로 해석될 수도 있었습니다. 그러나, 당사자의 진정한 의사와 합리적 상식을 고려하여 계약상 허용범위에서 배제한 사례입니다.

KASAN_특허실시, 기술이전, 라이선스 계약서에서 계약제품의 외주생산 허용범위 해석분쟁 판결 - 의료기기 Drug Elution Stent (DES) 관련 Exclusive License 분쟁 – 위수탁 생산, 판매행위와 assign 및 sub-l.pdf

17. MANUFACTURE AND SUPPLY OF CAPTISOL.

17.1 Supply.

(a) Subject to the terms and conditions of this Agreement, CyDex agrees to supply to Hospira those quantities of Captisol ordered by Hospira in accordance with Section 3.2 of this Agreement. So long as CyDex is able to deliver Captisol in accordance with the terms of this Agreement, except as provided in Section 3.11 (c) below, Hospira agrees that Hospira and its Affiliates shall during the Term order from CyDex no less than 90% of Hospira and its Affiliates aggregate requirements for Captisol for use in the formulation of Finished Product to be sold in the Major-Market countries.

(b) The parties hereby agree that [*] is CyDex’s Third-Party manufacturer of Captisol as of the Effective Date of this Agreement.

17.2 Purchase Orders. Hospira shall periodically submit firm purchase orders for Captisol to CyDex, which purchase orders shall set forth the specific quantities needed, the grade of Captisol required, delivery date and shipping instructions. Such purchase orders shall be submitted to CyDex at least [*] but not more than [*] prior to the required delivery date specified therein. If any purchase order or other document submitted by Hospira hereunder or any other document passing between the parties contains terms or conditions in addition to or inconsistent with the terms of this Agreement, the terms of this Agreement shall control and prevail and the parties hereby agree that such additional or inconsistent terms shall simply be ignored and deemed not to exist, unless they are expressly identified as being additional to or inconsistent with this Section 3.2 and are signed by officers of both parties.

17.3 Forecasts and Excess Demand. No later than the First Commercial Sale date, Hospira shall provide to CyDex a [*] forecast of its requirements for Captisol, with the first [*] of such forecast constituting a binding commitment upon Hospira to purchase such quantities under firm purchase orders submitted for the respective applicable [*] in accordance with Section 3.2. The balance of the forecast shall merely represent reasonable good-faith estimates for planning purposes only and shall not obligate Hospira to purchase any such amounts. On a [***] basis, Hospira shall update the forecast. If Hospira fails to provide any updated forecast in accordance with this Section 3.3, the forecast last provided by Hospira shall be deemed to be resubmitted as Hospira’s binding forecast for the next succeeding [*] period, and with the same quantity and timing as had been forecasted (or deemed to be forecasted) for the [*] of the prior forecast being repeated as the forecasted quantity and timing for the forecast’s [*]. CyDex shall notify Hospira as soon as possible, but in any event within [*] of the receipt of any forecast, if CyDex will be unable to deliver Captisol in accordance with such forecast. CyDex’s providing of such notification shall not be interpreted in any manner as relieving CyDex of its obligations under this Agreement, nor shall it prevent Hospira from pursuing any and all rights and remedies Hospira may have based on CyDex’s failure to be able to deliver Captisol in accordance with the terms of this Agreement. If any purchase order includes an Excess Demand, then (a) CyDex shall supply the quantity of Captisol which does not constitute an Excess Demand to Hospira in accordance with Section 3.2, and (b) CyDex shall use commercially reasonable efforts to supply the Excess Demand quantities of Captisol requested by Hospira in its purchase orders as soon as commercially possible.

17.4 Delivery Terms.

(a) CyDex agrees to deliver Captisol to Hospira’s carrier at a continental United States factory or warehouse designated by CyDex, in accordance with the purchase orders submitted by Hospira in accordance with Section 3.2 (each such delivery to be accompanied by a copy of the purchase order submitted by Hospira that corresponds to such delivery). All Captisol shall be delivered to Hospira using the carrier and in accordance with the delivery schedule specified by Hospira in its purchase orders. Captisol shall be delivered by CyDex to Hospira. CyDex will provide the carrier with proper instructions regarding how to transport the Captisol in conditions which will not adversely affect the Captisol, including ensuring that the shipment is temperature monitored and the Captisol is kept at an appropriate temperature throughout shipment.

(b) If CyDex is unable to deliver the Captisol on the date specified by Hospira, CyDex shall notify Hospira as soon as possible, but in any event within [***] of receipt of the purchase order. CyDex’s providing of such notification shall not be interpreted in any manner as relieving CyDex of its obligations under this Agreement, nor shall it prevent Hospira from pursuing any and all rights and remedies Hospira may have based on CyDex’s failure to deliver the Captisol in accordance with the terms of this Agreement.

(c) With each shipment of Captisol, CyDex shall, if so requested, provide by reference or otherwise all documentation as is reasonably required by any [*] from time to time in connection with Hospira’s research, development, modification, manufacture, importation, exportation, use, promotion, marketing, distribution, packaging, offering for sale, selling, and otherwise commercially exploitation, as applicable, of Captisol or the Finished Product. If such documentation is not supplied Hospira may reject the Captisol.

17.5 Safety Stock. Within [*] of CyDex’s receipt of the first purchase order from Hospira, CyDex shall establish and maintain a safety stock of at least [*] of Captisol available to Hospira based on Hospira’s latest forecast provided under Section 3.3. CyDex shall keep Hospira reasonably informed of the level of inventory identified as the safety stock and shall notify Hospira in the event any deliveries to Hospira deplete the current safety stock levels.

17.6 Failure to Supply.

(a) CyDex shall maintain sufficient capacity to manufacture Hospira’s projected needs for Captisol during the Term. If CyDex fails to deliver or anticipates that it will be unable to deliver any quantity of Captisol ordered pursuant to the terms of this Agreement for [*], CyDex will promptly notify Hospira. If CyDex fails to deliver any quantity of Captisol for [*], if such notice is received from CyDex, or if upon request by Hospira CyDex fails to provide adequate assurance of its ability to continue to deliver Captisol as required by the terms of this Agreement, then Hospira in its sole discretion and without impairing or limiting any other rights that Hospira may have under this Agreement or under applicable law, including, without limitation, its rights under Sections 2-609 and 2-610 of the Uniform Commercial Code, shall have the right to agree to a revised delivery date or Hospira may: [***] above, CyDex shall assist Hospira, if so requested by Hospira, by [*].

(d) Alternate Manufacturers. If CyDex fails to supply to Hospira, or if CyDex will be unable to supply Hospira with [***]% or more of the quantity of Captisol properly forecasted and ordered by Hospira in accordance with this Agreement, for a period of [*] then CyDex shall immediately provide written notice to Hospira of the [*]. In the event of a [*] in addition to any other rights and remedies Hospira may have under this Agreement, or in equity, or at law:

17.7 Inspection and Acceptance.

(a) CyDex shall test and inspect each lot of Captisol for compliance with Specifications prior to the release and shipment thereof to Hospira. CyDex will provide a Certificate of Analysis with each shipment of each lot of Captisol signed by the responsible quality official of CyDex. This Certificate of Analysis must include the results (whether numerical or otherwise) for each test performed that verifies that the Captisol is in compliance with the Specifications, as well as a statement that the subject lot was manufactured in accordance with the appropriate DMF/CEP. To the extent that any reference standard material is delivered to Hospira along with any shipment of Captisol as a result of Hospira’s request for such material pursuant to Section 3.2 of this Agreement, the Certificate of Analysis shall also include specifications on such material for each criterion listed in Exhibit B hereto, which specifications shall meet or exceed the Specifications.

(b) Hospira may test and inspect the Captisol after receipt and either accept or reject it. Captisol may be rejected if it does not comply with the Specifications or is otherwise defective. Hospira will be deemed to have accepted the Captisol, except as to latent defects which are not reasonably discoverable, if Hospira fails to give notice of rejection within [*] after receipt by Hospira of such Captisol. The written notice of rejection shall be given to CyDex and shall include identification of the lot number and description of the Specification failure or other defect.

(c) Following receipt of written notice of rejection of a particular lot of Captisol, in addition to any other rights or remedies Hospira may have under this Agreement, in equity, or at law, CyDex shall, at Hospira’s option, provide a credit, refund or prompt replacement of Captisol to Hospira; provided, however, that if CyDex does not agree with Hospira’s claim of noncompliance with Specifications or other defect, then the parties shall designate a mutually acceptable Third Party laboratory to make a determination on such matter from a sample obtained from the batch or other quantity shipped to Hospira. The decision of the Third Party laboratory shall be binding on all parties hereto and all expenses related to such Third Party investigation shall be borne by the party found to have been mistaken. Should such Third Party laboratory confirm Hospira’s claim, CyDex shall, at Hospira’s request, promptly provide Hospira with a credit, refund or prompt replacement of Captisol to Hospira.

(d) Hospira shall return any rejected Captisol to CyDex at CyDex’s expense to an address that CyDex may designate within [*] of CyDex receiving written notice of rejection; provided, however, that if CyDex does not agree with Hospira’s claim of noncompliance with Specifications or other defect, Hospira shall not be obligated to return the rejected Captisol to CyDex until [*] after a final determination is made by a Third Party laboratory that such Captisol does not comply with Specifications or is otherwise defective as provided in subparagraph (c) above. Absent such designation of address, Hospira will ship rejected Captisol to CyDex’s facility at [*], or such other address as CyDex may previously have given written notice of to Hospira as being the default address for return of rejected Captisol. All freight, insurance and other costs of such shipment along with any risk of loss shall be borne by CyDex, and shipment will be made from Hospira’s designated plant.

(e) Hospira’s rights of rejection, return, refund and replacement set forth in this Section 3.7 shall not apply to any Captisol that is non-conforming due to damage that occurs after delivery of such Captisol to Hospira’s carrier at the point of origin that is caused by Hospira, any of its Affiliates’ or their respective employees or agents’ negligence or willful misconduct, including but not limited to, misuse, neglect, improper storage, transportation or use beyond any dating provided.

17.8 Quality Agreement. The parties shall on the Effective Date enter into a separate Quality Agreement, in the form attached hereto as Exhibit D. The parties shall comply with the terms of the Quality Agreement, and any breach of the Quality Agreement shall be deemed a breach of this Agreement.

17.9 Quality Assurance. Each lot of Captisol to be supplied to Hospira hereunder shall be subject to a quality assurance inspection by CyDex in accordance with CyDex’s then current quality assurance standards and the Quality Agreement, which standards shall be designed to ensure that the Captisol meets the requirements of the Specifications and is manufactured per Good Manufacturing Practices.

17.10 Process Change Provisions and Procedure.

(a) General. To the extent pertaining to Captisol to be delivered pursuant to this Agreement, all modifications, changes, additions or deletions to the (i) Specifications; (ii) changes in the expiration period for Captisol; (iii) composition or source of any raw material for Captisol; (iv) method of producing, processing or testing Captisol; (v) change in subcontractors for producing, processing or testing Captisol; or (vi) site of manufacture for Captisol, which CyDex intends to carry out must be evaluated and documented by CyDex. [*], CyDex shall if so required amend its DMF/CEP through the appropriate notification to the FDA and any other applicable Regulatory Authorities. [*].

(b) Required Changes. Any changes relating to the Specifications or manufacturing processes for Captisol hereunder that are required by any applicable laws or other Regulatory Authority requirements in any Major Market, or by medical concerns related to the toxicity, safety and/or efficacy of Captisol shall hereinafter be referred to as “Required Changes”. The parties shall cooperate in making such changes promptly.

KASAN_제약회사의 API 공급, 완제품 생산위탁, 완제품구매 계약서에서 원료공급 및 생산 관련 계약조항 영문 샘플.pdf

[질문 또는 상담신청 입력하기]

“Net Sales” means, with respect to a given period of time, gross sales of the Product in such period to unrelated Third Parties in bona fide arm’s length transactions, (excluding sales or dispositions for use in Clinical Studies or other scientific testing or reasonable quantities of samples, in each case for which Licensee and any such Third Party Distributors receive no revenue), less the following deductions which are actually incurred, allowed, paid, accrued or specifically allocated to such gross sales amounts of the Product and not separately invoiced:

(a) credits or allowances actually granted for damaged Product, returns or rejections of Product, price adjustments, and billing errors;

(b) governmental and other rebates (or equivalents thereof) granted to: managed health care organizations; pharmacy benefit managers (or equivalents thereof); federal, state/provincial, local and other governments, their agencies and purchasers and payors, including, without limitation, any state or federal Medicare, Medicaid or similar program); or trade customers;

(c) normal and customary trade, cash and quantity discounts, allowances and credits actually allowed and taken specifically with respect to sales of other dispositions of the Product;

(d) distribution services agreement fees allowed or paid to Third Party distributors;

(e) transportation costs, including without limitation insurance, for outbound freight related to delivery of the Product to the extent included in the gross amount invoiced;

(f) excise and sales taxes, tariffs, duties, value added taxes, and other taxes applied to the sale of the Product imposed upon and paid directly with respect to such sales or (reduced by any refunds of such taxes deducted in the calculation of Net Sales for prior periods and, for the avoidance of doubt, no deduction shall be permitted for income, withholding, corporate or similar taxes); and

(g) any other items that reduce gross sales amounts as required by GAAP.

Transfers and sales of the Product between or among a Party and its Affiliates or Third Party Distributors shall be excluded from the computation of Net Sales, but the subsequent final sales of the Product to Third Parties by such Affiliates or Third Parties shall be included in the computation of Net Sales.

There shall be no double counting in determining the foregoing deductions from gross amounts invoiced to calculate Net Sales. The deductions set forth above in this definition of Net Sales shall be determined in accordance with GAAP, as consistently applied by Licensee and such Third Party Distributors across all of their products. The amounts set forth in clauses (a) through (g) above shall only be deducted from gross invoiced sales where gross invoiced sales before deductions are non-discounted gross sales amounts.

In the event Licensee or such Third Party Distributors sell the Product together with other products to Third Parties in a particular country in the Territory and the price attributable to the Product is less than the average price of “arm’s length” sales of the Product alone in the particular country for the reporting period in which such sales occur (such sales to be excluded from the calculation of the average price of “arm’s length“ sales of the Product alone), Net Sales for any such sales shall be the average price of “arm’s length” sales by Licensee or Third Party Distributors, as applicable, of the Product alone and in the country during the reporting period in which such sales occur. If the average price of “arm’s length” sale of the Product cannot be determined in any given country, the Net Sales will be determined by the value of the Product sold to similar customers in countries with similar pricing and reimbursement structures and for similar quantities. Any dispute as to the determination of fair market value that cannot be resolved through discussion between the Parties shall be determined in accordance with Section 3.2(i). Notwithstanding the foregoing, in the event the Product is sold as a Combination Product, for purposes of determining the royalties payable by Licensee to Licensor hereunder, Net Sales shall be calculated by the Net Sales for such Combination Product in a manner to be negotiated and agreed upon by Licensor and Licensee, reasonably and in good faith, prior to any sale of such Combination Product, which shall be based upon the respective fair market values of the active pharmaceutical ingredients in such Combination Product; provided that in no event shall the royalty rate payable by Licensee to Licensor for such Combination Product be greater than the royalty rate of the Product containing the Compound as the sole active ingredient.

KASAN_라이선스, 특허실시, 기술이전, License 계약에서 Running Royalty 산정기준 Net Sales 정의 영문계약 조항 샘플 – 상세하게 기재한 방식 사례.pdf

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4.1 License Fees. On or before the Effective Date, the Licensee Kite shall pay to the Licensor Cabaret a one-time upfront license fee of twenty-five thousand United States dollars (US$25,000). On or before each anniversary of the Effective Date until First Commercial Sale of the first Licensed Product, Kite shall pay to Cabaret an annual license fee of thirty thousand dollars (US$30,000).

4.3 Royalties.

4.3.1 Royalty Rate. During the applicable Royalty Term for a Licensed Product, subject to the terms and conditions of this Agreement, Kite shall pay to Cabaret royalties, with respect to each Licensed Product, equal to [*] percent ([*]%) of Net Sales of such Licensed Product by the Licensee Kite, its sublicensees and their respective Affiliates; provided, however, if the Licensed Product is made, used, or sold in such country where such Licensed Product would not infringe a Valid Claim, then the applicable royalty rate for such Licensed Product in such country shall be reduced to [*] percent ([*]%) of Net Sales of such Licensed Product. Only one royalty shall be owing for a Licensed Product regardless of how many Valid Claims cover such Licensed Product.

4.3.2 Third Party Royalties. If the Licensee Kite, its Affiliate or Sublicensee is required to pay royalties in consideration for a license to such Third Party IP to any Third Party in order to exercise its rights hereunder to make, have made, use, sell, offer to sale or import any Licensed Product, then Kite shall have the right to credit [*] percent ([*]%) of such Third Party IP royalty payments against the royalties owing to Cabaret under Section 4.3.1 with respect to sales of such Licensed Product in such country; provided, however, that Kite shall not reduce the amount of the royalties paid to Cabaret under Section 4.3.1 by reason of this Section 4.3.2, with respect to sales of such Licensed Product in such country, to less than [*] percent ([*]%) of Net Sales of such Licensed Product in such country.

4.3.3 Generic Product. On a country-by-country and Licensed Product-by-Licensed Product basis, if at any time during the applicable Royalty Term, one or more Generic Products are commercially launched by a Third Party (other than a Third Party sublicensee) in a country, then the applicable royalty rate for such Licensed Product in such country shall be reduced to [*] percent ([*]%) of Net Sales of such Licensed Product beginning from the launch of such Generic Product and continuing so long as such Generic Product is being sold in such country. Notwithstanding anything to the contrary set forth in this Agreement, to the extent that Kite has entered into a Sublicense Agreement pursuant to which Kite is not entitled to receive royalties in a country in which a Generic Product has been commercially launched, Kite shall have no obligation to pay, and Cabaret shall have no right to receive, royalties with respect to sales of Licensed Product in such country.

4.3.4 Combination Products. If a Licensed Product either (a) is sold together with another active ingredient product or device product which is not covered by a Valid Claim for a single price, or (b) consists of components that are covered by a Valid Claim and an active ingredient or device component that is not covered by a Valid Claim, then (except in the case where (i) the other active ingredient or device product or component which is not covered by Valid Claim also is not covered by any other valid patent claim, and (ii) a sublicensee pays to Kite a royalty which is not subject to an adjustment for such other active ingredient or device product or component) for purposes of the royalty payments under Section 4.3 for Net Sales of such Licensed Products, such Net Sales, prior to the royalty calculation set forth in Section 4.3, first shall be multiplied by the fraction A/(A+B), where A is [*], and B is [*]. If the parties cannot reach an agreement as to the Value of each of the products or components then a Third Party arbitrator who is an industry expert shall be appointed to provide such determination which shall be binding on the parties. The parties shall equally share all costs associated which such determination. Until such determination is made Kite shall make payment under Section 4.3 to Cabaret in accordance with its own determination and if following the Third Party arbitrator’s decision an increase in payments is required Kite shall make such adjustment payments retroactively.

KASAN_특허라이선스, 기술이전 계약서에서 대가지급, Royalty 계약조항 샘플.pdf

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