Back to top

AMENDED AND RESTATED COLLABORATION AGREEMENT

Collaboration Agreement

AMENDED AND RESTATED 

COLLABORATION AGREEMENT | Document Parties: ALIMERA SCIENCES, INC | CONTROL DELIVERY SYSTEMS, INC | PSIVIDA, INC You are currently viewing:
This Collaboration Agreement involves

ALIMERA SCIENCES, INC | CONTROL DELIVERY SYSTEMS, INC | PSIVIDA, INC

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: AMENDED AND RESTATED COLLABORATION AGREEMENT
Governing Law: New York     Date: 5/12/2008
Industry: Biotechnology and Drugs     Law Firm: Ropes Gray     Sector: Healthcare

AMENDED AND RESTATED 

COLLABORATION AGREEMENT, Parties: alimera sciences  inc , control delivery systems  inc , psivida  inc
50 of the Top 250 law firms use our Products every day

EXHIBIT 10.1

Revised Execution Version

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

AMENDED AND RESTATED

COLLABORATION AGREEMENT

BY AND BETWEEN

PSIVIDA, INC. (f/k/a CONTROL DELIVERY SYSTEMS, INC.)

AND

ALIMERA SCIENCES, INC.

DATED AS OF MARCH 14, 2008

 


TABLE OF CONTENTS

 

          Page

ARTICLE 1

   DEFINITIONS    1

ARTICLE 2

   Intentionally omitted    17

ARTICLE 3

   DEVELOPMENT ACTIVITIES    17

3.1    

   General    17

3.2    

   Regulatory Approvals.    18

3.3    

   Performance.    19

3.4    

   Primary Contact Persons    20

3.5    

   Availability of Employees    20

3.6    

   Visit of Facilities    20

3.7    

   Subcontracts    20

3.8    

   Information Sharing    20

3.9    

   Records    21

3.10  

   Manufacturing for Clinical Supply Requirements    21

3.11  

   Technology Transfer by CDS    21

ARTICLE 4

   COMMERCIALIZATION    22

4.1    

   Commercialization of Product(s) in the Collaboration Field    22

4.2    

   Commercialization Budget    22

4.3    

   Diligence    23

4.4    

   Costs of Commercialization    25

4.5    

   Manufacturing for Commercial Supply Requirements    26

4.6    

   Product Recalls    26

ARTICLE 5

   GRANT OF RIGHTS    27

5.1    

   Grant of License by CDS.    27

5.2    

   Grant of License by Alimera    27

5.3    

   Sublicenses and Subcontracts    28

5.4    

   Ownership of and Rights to Inventions    29

5.5    

   Limitation on Use    29

5.6    

   Reservation of Rights.    29

5.7    

   No Grant of Other Technology or Patent Rights    30

 

-ii-

 


5.8    

   Options to Licenses in the Collaboration Field.    30

5.9    

   Clinical IP.    32

5.10  

   Section 365(n) of the Bankruptcy Code    32

ARTICLE 6

   COSTS & REVENUES – PRE AND POST PROFITABILITY DATE    32

6.1    

   License Fee    32

6.2    

   Milestone Payments    33

6.2A  

   Payments on Execution of Amended and Restated Agreement    33

6.2B  

   Certain Alimera Note Payments and Events    33

6.3    

   Development Costs    33

6.4    

   Revenues Prior to Profitability Date    34

6.5    

   Costs and Revenues After the Profitability Date.    34

6.6    

   Revenues from Third Party Agreements    37

6.7    

   Records; Audits.    37

ARTICLE 7

   INTELLECTUAL PROPERTY    38

7.1    

   CDS-Prosecuted Patent Rights.    38

7.2    

   Abandonment    39

7.3    

   Alimera-Prosecuted Patent Rights.    40

7.4    

   Information Disclosure; Cooperation    41

7.5    

   Employees and Sublicensees Assignment of Inventions    41

7.6    

   Infringement    41

7.7    

   Marking    44

7.8    

   Trademarks    44

7.9    

   UKRF Licenses and B&L Agreement    45

ARTICLE 8

   CONFIDENTIALITY    45

8.1    

   Confidentiality    45

8.2    

   Disclosure    45

8.3    

   Disclosure of Agreement    46

8.4    

   Disclosure of Product Achievements    46

ARTICLE 9

   REPRESENTATIONS AND WARRANTIES    46

9.1    

   Representations and Warranties of CDS    46

9.2    

   Representations and Warranties of Alimera    48

 

-iii-

 


9.3    

   Warranty Disclaimer    48

9.4    

   Limited Liability    48

ARTICLE 10

   INDEMNITY    49

10.1    

   Cross Indemnity    49

10.2    

   Limitation on Indemnity Obligations    49

10.3    

   Procedure    49

10.4    

   Insurance    50

10.5    

   Product Liability Claims    50

ARTICLE 11

   TERM AND TERMINATION    51

11.1    

   Term    51

11.2    

   Termination for Default by Either Party    51

11.3    

   Intentionally omitted.    52

11.4    

   Intentionally omitted.    52

11.5    

   Termination for Abandonment    52

11.6    

   Effect of Expiration or Termination of the Agreement    53

11.7    

   Survival of Provisions Upon Expiration or Termination    53

ARTICLE 12

   MISCELLANEOUS    53

12.1    

   Interpretation.    53

12.2    

   Assignment    54

12.3    

   Severability    54

12.4    

   Notices    54

12.5    

   Governing Law and Venue    55

12.6    

   Compliance with Applicable Laws    55

12.7    

   Dispute Resolution    56

12.8    

   Intentionally omitted    56

12.9    

   Entire Agreement    56

12.10  

   Headings    57

12.11  

   Independent Contractors    57

12.12  

   Waiver    57

12.13  

   Counterparts    57

 

-iv-

 


AMENDED AND RESTATED COLLABORATION AGREEMENT

THIS AMENDED AND RESTATED COLLABORATION AGREEMENT (the “ Agreement ”) dated as of March 14, 2008 (the “ Amendment Effective Date ”), is made by and between PSIVIDA, INC. (f/k/a CONTROL DELIVERY SYSTEMS, INC.), a corporation organized and existing under the laws of the State of Delaware having its offices at 400 Pleasant St., Watertown, Massachusetts 02472 (“ CDS ”), and ALIMERA SCIENCES, INC., a corporation organized and existing under the laws of the State of Delaware having its offices at 6120 Windward Parkway, Alpharetta, GA 30005 (“ Alimera ”). CDS and Alimera are sometimes referred to herein individually as a “ Party ” and collectively as the “ Parties .”

RECITALS

WHEREAS, CDS designs and develops innovative ophthalmic drug delivery products; and

WHEREAS, Alimera develops and commercializes ophthalmic drug products; and

WHEREAS, the Parties were interested in collaborating with one another and jointly funding the development, and sharing Net Profits from the sale, of novel products for treating eye diseases in humans, including a product for the treatment of diabetic macular edema using a corticosteroid; and

WHEREAS, CDS was willing to grant Alimera a license to certain of its proprietary technology and know-how relating to developing products for treating eye diseases; and

WHEREAS, the Parties entered into such a collaboration and licensing relationship upon the terms and conditions set forth in the Collaboration Agreement by and between Control Delivery Systems, Inc. and Alimera Sciences, Inc. (the “ Original Agreement ”) dated as of February 11, 2005 (the “ Effective Date ”), as amended by Amendment No. 1 dated February 23, 2005 and Amendment No. 2 dated May 11, 2005; and

WHEREAS, CDS and Alimera desire to enter into this Agreement to amend and restate the Original Agreement (as amended prior to the Amendment Effective Date) as of the Amendment Effective Date as set forth herein;

NOW THEREFORE, in consideration of the premises and of the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:

ARTICLE 1 DEFINITIONS

For purposes of this Agreement, the terms defined in this Article shall have the meanings specified below, whether used in their singular or plural form:

1.1 “Affiliate” shall mean any corporation or other entity that controls, is controlled by, or is under common control with a Party to this Agreement. A corporation or other entity shall be regarded as in control of another corporation or entity if it directly or indirectly owns or controls more than fifty percent (50%) of the voting stock or other ownership interest of the other corporation or

 

1

 


entity, or if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation or other entity or the power to elect or appoint more than fifty percent (50%) of the members of the governing body of the corporation or other entity.

1.1A “Alimera Development Activities” shall mean (a) for activities conducted prior to the Amendment Effective Date, Alimera’s development activities conducted as set forth in the Development Plan (as defined in the Original Agreement) and (b) for activities conducted on and after the Amendment Effective Date, all Alimera development activities related to this Agreement.

1.2 “Alimera Improvements” shall mean any and all Improvements created, conceived or reduced to practice by Alimera, or its Affiliates, agents, subcontractors or sublicensees, alone or with others, or by Third Parties acting on their behalf, that are (a) Improvements covered by or derived from practice of the CDS Technology, and/or (b) Improvements covered by or derived from the practice of the Improvements set forth in clause (a); provided, however, that Alimera Improvements shall not include any Improvement that meets each of the following: (x) is related specifically to an active ingredient provided by Alimera and used in the Products, (y) can be practiced without infringing any CDS Existing Patent Rights and any Patent Rights included within CDS Improvements, or without utilizing any CDS Know-How, and (z) does not fall within the definition of the CDS Core Technology.

1.3 “Alimera Know-How” shall mean Know-How Controlled by Alimera.

1.3A “Alimera Note” shall have the meaning set forth in Section 6.2A.

1.4 “Alimera Patent Costs” shall mean fees and costs associated with filing, prosecution and maintenance of the Alimera-Prosecuted Patent Rights, as defined in Section 7.3, in the Territory.

1.4A “AMD” means age-related macular degeneration.

1.4B “Amendment Effective Date” shall have the meaning set forth in the preamble.

1.5 “Approval” shall mean the approvals from applicable regulatory authorities in any country or region required to lawfully market a Product in such country or region, including, but not limited to, approval of an NDA. The term “Approved” shall mean the receipt of Approval.

1.6 “Bankruptcy Code” shall mean Title 11 of the United States Code, as amended from time to time.

1.7 “B&L” shall mean Bausch & Lomb Incorporated.

1.8 “B&L Agreement” shall mean the Amended and Restated License Agreement between CDS and B&L dated as of December 9, 2003 as in existence and effect on the Effective Date, a full and complete copy of which has been provided to Alimera.

 

2

 


1.9 “Business Day” shall mean each day of the week excluding Saturday, Sunday and U.S. federal holidays.

1.10 “CDS Core Technology” shall mean (a) any drug delivery device, or component thereof, for ophthalmic use that includes a core containing one or more drugs, and (b) any method or process for using a device described in clause (a).

1.10A “CDS Development Activities” shall mean (a) for activities conducted prior to the Amendment Effective Date, CDS’ development activities conducted as set forth in the Development Plan (as defined in the Original Agreement) and (b) for activities conducted on and after the Amendment Effective Date, CDS’ development activities conducted to the extent specifically set forth in Section 3.1.2 herein.

1.11 “CDS Existing Patent Rights” shall mean (a) the United States and foreign patents and patent applications listed in Exhibit 1.11A , (b) any Patent Rights arising from those patents and patent applications during the Term, and (c) any other patents or patent applications Controlled by CDS as of the Effective Date, a Valid Claim of which, absent the licenses granted by CDS to Alimera under Section 5.1, would be infringed by the making, having made, using, selling, offering to sell or importing of a Product in the Collaboration Field by Alimera or its subcontractors or sublicensees as permitted under this Agreement; provided, however, that CDS Existing Patent Rights shall in no event include the patents and patent applications listed in Exhibit 1.11B or any Patent Rights arising from those patents or patent applications.

1.12 “CDS Improvements” shall mean any and all Improvements created, conceived or reduced to practice by CDS, or its Affiliates, agents, or sublicensees, alone or with others or by Third Parties acting on their behalf, during the course of CDS Development Activities, that are (a) Improvements covered by or derived from practice of the CDS Technology, and/or (b) Improvements covered by or derived from the practice of the Improvements set forth in clause (a); provided, however, that CDS Improvements shall not include any Improvement that is an Alimera Improvement.

1.13 “CDS Know-How” shall mean Know-How Controlled by CDS that is required for development and Commercialization of a Product.

1.14 “CDS Net Income” or “CDS Net Losses” shall mean, for the first calendar quarter after the CDS Profitability Date and for any calendar quarter thereafter, Net Sales by CDS, and/or CDS Sublicense Revenue actually received by CDS, for a Product in that calendar quarter minus the CDS Product Costs for such Product in that calendar quarter; provided that in the event any portions of the CDS Product Costs are already included in arriving at CDS Sublicense Revenue, such portions of the CDS Product Costs shall be excluded from the above calculation to determine the CDS Net Income or CDS Net Losses. To the extent Net Sales and/or CDS Sublicense Revenue actually received by CDS exceed the CDS Product Costs for the relevant calendar quarter, such amount of difference shall be deemed “CDS Net Income,” and to the extent CDS Product Costs exceed Net Sales and/or CDS Sublicense Revenue actually received by CDS for the relevant calendar quarter, the amount of such difference shall be deemed “CDS Net Losses.” For clarification, with respect to calculating CDS Net Income for any unit of Product, the Manufacturing Cost incurred to manufacture such unit shall be deemed to be incurred in that country and quarter in which such unit is sold.

 

3

 


1.15 “CDS Patent Costs” shall mean fees and costs associated with filing, prosecution and maintenance of the CDS-Prosecuted Patent Rights, as defined in Section 7.1.2, in the countries listed on Exhibit 1.15 .

1.16 “CDS Patent Rights” shall mean CDS Existing Patent Rights and CDS’ interest in any Patent Rights included within Alimera Improvements and CDS Improvements.

1.17 “CDS Product Costs” shall mean, with respect to a Product, all costs CDS incurred for developing and Commercializing such Product, including, without limitation, the following costs: (a) all Direct Development Costs incurred by CDS during the Term of this Agreement, (b) each of the following to the extent paid by CDS to Alimera pursuant to this Agreement: all Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Payments (as all defined in the Original Agreement), (c) each of the following, if any, owed by Alimera to CDS to the extent not already paid by Alimera: any Compounded Development Payments and Compounded Disputed Payments (as both defined in the Original Agreement), plus any interest on such unpaid amount that has accrued in accordance with the terms of this Agreement after termination of either this entire Agreement or this Agreement with respect to a Product, as applicable, (d) each of the following to the extent not already included in Direct Development Costs or reimbursed by Alimera: CDS Patent Costs, UKRF Costs and insurance premiums paid by CDS to maintain insurance required by Section 10.4, as compounded, if applicable, pursuant to Section 4.4, and (e) any other costs incurred by CDS for developing and Commercializing such Product.

1.18 “CDS Profitability Date” shall mean, with respect to a Product, the first day of the first calendar quarter in which the aggregate of Net Sales by CDS, and CDS Sublicense Revenue actually received by CDS, of such Product for all preceding calendar quarters and the current calendar quarter exceeds the CDS Product Costs during all preceding calendar quarters and the current calendar quarter; provided that in the event that any portions of the CDS Product Costs are already included in arriving at the CDS Sublicense Revenue, such portions of the costs shall be excluded from the above calculation to determine the CDS Profitability Date. For clarification, all preceding calendar quarters include the Term of this Agreement and for any applicable periods thereafter.

1.19 “CDS Sublicense Revenue” shall mean any form of consideration (excluding any amounts paid for equity securities of CDS other than amounts that exceed the fair market value of such securities) in connection with a sublicense agreement that CDS enters into with a Third Party to sell or otherwise transfer some or all of CDS’ rights to a Product, including, but not limited to, marketing rights and/or distribution rights, provided that (1) the fair market value of such securities shall be determined by mutual agreement of both Parties, and (2) in the event that the Parties fail to reach such mutual agreement, the matter shall be resolved by arbitration in accordance with Section 12.7.2 herein.

1.20 “CDS Technology” shall mean CDS Patent Rights, CDS Know-How and CDS’ interest in Alimera Improvements and CDS Improvements.

 

4

 


1.21 “Change of Control” shall mean, with respect to a Party, (a) a merger or consolidation of such Party with a Third Party which results in the voting securities of such Party outstanding immediately prior thereto ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger or consolidation, or (b) except in the case of a bona fide equity financing in which a Party issues new shares of its capital stock, a transaction or series of related transactions in which a Third Party, together with its Affiliates, becomes the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of such Party, or (c) the sale or other transfer to a Third Party of all or substantially all of such Party’s assets related to the Collaboration Field.

1.22 “Clinical IP” shall mean (a) all preclinical and clinical protocols, studies, data, results, study-related forms, materials and reports (e.g., investigator brochures, informed consent forms, data safety monitoring board related documents, patient recruitment related materials, biocompatibility studies, animal studies, safety studies, and chemistry, manufacturing and control data) resulting from any preclinical or clinical study or trial of any Product in the Collaboration Field that is conducted by or under the direction of Alimera or CDS, or their Permitted Subcontractors or sublicensees, pursuant to this Agreement, and any audit of any such preclinical or clinical study or trial, and (b) all INDs, NDAs, any unfiled applications, components or materials normally associated with an IND or NDA, regulatory filings or applications comparable to INDs or NDAs in any foreign jurisdictions, and other regulatory applications and Approvals regarding any Product in the Collaboration Field that are prepared or submitted by or under the direction of Alimera or CDS, or their Permitted Subcontractors or sublicensees, pursuant to this Agreement; provided, however, that Clinical IP shall not include any Pre-Existing Clinical IP.

1.23 “Clinical Supply Requirements” shall mean, with respect to each Product, the quantities of such Product that are required for the conduct of preclinical studies and clinical trials required to procure data necessary for the acceptance of filing of an NDA for the Product, pursuant to the Development Activities. For the avoidance of doubt, supplies for Non-NDA Trials are excluded from the definition of Clinical Supply Requirements.

1.24 “CODRUG™” shall mean a compound or a pharmaceutically acceptable salt thereof comprising one constituent moiety covalently or ionically associated with at least one other constituent moiety, wherein each moiety, in its separate form (i.e., in the absence of the association), is a therapeutically or pharmacologically active agent or a prodrug or pharmaceutically acceptable salt of such an agent. The covalent association between said moieties can be either direct or indirect through a linker. Examples of covalent association include without limitation ester, amide, carbamate, carbonate, cyclic ketal, thioester, thioamide, thiocarbamate, thiocarbonate, xanthate, and phosphate ester bonds. Each constituent moiety of a CODRUG™ compound can be the same as or different from the other constituent moiety. Upon cleavage of the covalent or ionic association, the individual constituent moieties are reconstituted as the therapeutically or pharmacologically active forms of the same moieties prior to conjugation.

 

5

 


1.25 “Collaboration Field” shall mean the treatment and prevention of eye diseases in humans; provided, however, that the treatment and prevention of [*] is excluded from the Collaboration Field.

1.26 “Commercial Supply Requirements” shall mean, with respect to each Product, quantities of such Product that are required to fulfill requirements for commercial sales, Product sampling, and Non-NDA Trials, in the Collaboration Field in the Territory.

1.27 “Commercialize” or “Commercialization” shall mean any and all activities directed to marketing, promoting, Detailing, distributing, importing, offering for sale, having sold and/or selling a product, including, but not limited to, sampling, and conducting Non-NDA Trials.

1.28 “Commercialization Budget” shall have the meaning set forth in Section 4.2 hereof.

1.29 “Commercially Reasonable Efforts” shall mean efforts and resources that parties in the pharmaceutical industry would consider normal to use for a compound or product owned by a party in that industry or to which that party has rights, which is of similar market potential at a similar stage in its development or product life, taking into account the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory structure involved, the profitability of the applicable products, and other relevant factors. In determining Commercially Reasonable Efforts with respect to a particular Product, a Party may not consider any other product(s) owned or licensed by it.

1.30 Intentionally omitted.

1.31 “Confidential Information” shall have the meaning set forth in Section 8.1 hereof.

1.32 “Control” or “Controlled by” shall mean, in the context of a license to or ownership of intellectual property, possession of the ability on the part of a Party to grant access to or a license or sublicense as provided for herein without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Party would be required hereunder to grant the other Party such access or license or sublicense.

1.33 “Detail” shall mean a face-to-face meeting (including a live video presentation) with one or more healthcare professionals with prescribing authority during which scientific and/or medical information about the Product is discussed. Detailing does not include merely a reminder or a promotional sample drop. When used as a verb, the term “Detailing” shall mean to engage in the activity of a Detail.

1.33A “Development Activities” shall mean the Alimera Development Activities and CDS Development Activities.

 

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

 

6

 


1.34 Intentionally omitted.

1.35 Intentionally omitted.

1.36 “Direct Commercialization Costs” shall mean only the following costs incurred, on a cash basis, by Alimera for Commercializing a Product in accordance with this Agreement and pursuant to the Commercialization Budget:

(a) Direct Costs of marketing activities for the Product, including pre-launch, launch, advertising, packaging, activities necessary for seeking and maintaining pricing and reimbursement approvals from Third Party payors, literature, lectures, training (including wet labs for training healthcare professionals) and sales promotion;

(b) [*]

(c) Direct Costs associated with maintaining Approvals for the Product;

(d) Direct Costs of package development and package maintenance for the Product;

(e) Selling Expenses for the Product;

(f) Manufacturing Costs to satisfy Commercial Supply Requirements for the Product;

(g) Direct Costs of distribution of the Product other than the costs specified in Section 1.60(d);

(h) Royalties, milestones and other fees paid by Alimera under Third Party license(s) [*] that are at arms’ length to the extent they relate to the Product, to the extent such licenses are necessary for Alimera to make, have made, use, offer to sell, sell, and import the Product without infringing patents of such Third Parties, including without limitation as provided for in Section 7.6.4;

(i) Direct Costs of selection, filing, prosecution and maintenance of trademarks used solely for the Product (or an appropriate allocation in the case of any trademarks used for the Product and other products);

(j) Direct Costs of Medical Advisory Services for the Product;

(k) Recall expenses that are Direct Commercialization Costs as set forth in Section 4.6;

 

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

 

7

 


(l) Product Liability Losses that are Direct Commercialization Costs as set forth in Section 10.5;

(m) Insurance premiums paid by Alimera for the insurance required by Section 10.4 to the extent such insurance relates to Commercialization of the Product (i.e., if insurance covers risks other than risks related to Commercialization of the Product, then only an appropriate portion of such premiums shall be included); and

(n) Taxes, duties, tariffs and other governmental charges (excluding taxes on income) associated with manufacture and distribution of the Product, to the extent not deducted from Net Sales pursuant to Section 1.60(c).

Notwithstanding any other provisions in this Agreement, Direct Commercialization Costs shall include only the costs of labor for those individuals who spent greater than fifty percent (50%) of their time on activities within the Commercialization Budget during any calendar month (the “Majority Time Individuals”), and such costs shall be determined according to the amount of the Majority Time Individuals’ time actually spent on such Commercialization activities, provided that, if the Commercialization activity is Detailing, then such costs for the Majority Time Individuals shall be determined in accordance with Section 1.81. In the event there is more than one Product on the market at any given time, Direct Commercialization Costs attributable to more than one Product shall be allocated to each Product as appropriate; provided, however, that in no event shall any Direct Commercialization Costs be accounted for more than once. Notwithstanding the foregoing, in the event that a person devotes time to both activities under the Commercialization Budget and Development Activities, the time spent shall be aggregated in determining whether such person meets the fifty percent (50%) threshold set forth in this definition and in the definition of Direct Development Costs, and the person’s time shall be allocated accordingly between development and Commercialization. Notwithstanding anything else herein, no Direct Development Costs may be categorized as Direct Commercialization Costs.

1.37 “Direct Costs” shall mean, on a cash basis, the costs of labor (including only salaries, wages and current period employee benefits (but specifically excluding expenses associated with stock options or other equity-based or deferred compensation)), raw materials, supplies, services, fees, and other resources, directly and exclusively consumed or used in the conduct of the applicable activity; provided, however, that the following costs shall not be deemed Direct Costs: (i) corporate overhead expenses, including, but not limited to, general administration, business development, travel, entertainment, executive management, facilities, finance, information system and data management services, investor relations, human resources, legal, payroll, purchasing, and corporate supervisory services; (ii) amortization and depreciation expenses, interest expenses, taxes, extraordinary or nonrecurring losses customarily deducted by a Party in calculating and reporting consolidated net income, capital expenditures (including, but not limited to, purchases of facilities, property or equipment), and inventory write-offs (to the extent not attributable to a Product); (iii) consulting (including legal) fees unless specifically set forth in a mutually approved budget; and (iv) payments made to any related party or Affiliates in excess of an arm’s length charge for the relevant product or service.

 

8

 


1.38 “Direct Development Costs” shall mean the following costs incurred, on a cash basis, by either Party for developing a Product:

(a) Direct Costs for Development Activities for the Product, incurred, on a cash basis, by a Party or paid by a Party to Permitted Subcontractors, including, but not limited to, research, formulation development and testing, clinical development activities, data management, toxicology, and planning and execution of clinical trials required to procure data necessary for the acceptance of filing of an NDA;

(b) Manufacturing Costs to satisfy Clinical Supply Requirements;

(c) Direct Costs for regulatory filings pursuant to the Development Activities (specifically excluding any filing related to Non-NDA Trials) for the Product;

(d) Insurance premiums paid by either Party for commercial insurance to the extent such insurance relates to Development Activities in accordance with Section 10.4 hereof (i.e., if insurance covers risks other than risks related to development of the Product, then only an appropriate portion of such premiums shall be included);

(e) CDS Patent Costs paid from the Effective Date up to the first Product Profitability Date that are not otherwise reimbursed by a Third Party; provided, however, that CDS Patent Costs in excess of [*] in any calendar year shall not be included as Direct Development Costs;

(f) Direct Costs of the activities conducted under Section 3.11, including, but not limited to, technology transfer assistance from CDS to Alimera to enable Alimera to manufacture the Product for Commercialization;

(g) Direct Costs for capital expenditures to the extent attributable to the Product and part of Development Activities; and

(h) Other Direct Costs as mutually agreed upon by the Parties.

Notwithstanding any other provisions in this Agreement, Direct Development Costs shall (1) with the exception of (e) and (f) above, include only Direct Costs incurred, on a cash basis, in connection with activities conducted to procure data necessary for the acceptance of filing of an NDA for the Product; and (2) include only the costs of labor for those individuals who spent greater than fifty percent (50%) of their time on Development Activities during any calendar month, and such costs shall be determined according to the percentage of the individuals’ time actually spent on such development activities; and (3) not include any Commercialization costs. Notwithstanding the foregoing, in the event that a person devotes time to both activities under the Commercialization Budget and Development Activities, the time spent shall be aggregated in determining whether such person meets the fifty percent (50%)

 

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

 

9

 


threshold set forth in this definition and in the definition of Direct Commercialization Costs, and the person’s time shall be allocated accordingly between development and Commercialization.

1.39 “DME” shall mean diabetic macular edema.

1.40 “Effective Date” shall have the meaning set forth in the recitals.

1.41 “Earnest Money Loan” shall mean the aggregate of the loan under the Secured Promissory Notes from CDS to Alimera dated October 19, 2004, November 18, 2004 and December 22, 2004.

1.42 “Excluded Product” shall mean a [*] that generally conforms to the drawings and specifications (and any prior iterations thereof in whole or in part) shown in Exhibit 1.42 .

1.43 “FDA” shall mean the United States Food and Drug Administration or any successor agency with responsibilities comparable to those of the United States Food and Drug Administration.

1.43A “Fifty/Fifty Amendments” shall mean both of the following amendments:

(1) In the first sentence of Section 6.5.1, the words “Alimera and CDS shall be entitled to eighty percent (80%) and twenty percent (20%), respectively,” shall be deleted and the words “each Party shall be entitled to fifty percent (50%)” shall be substituted in their place.

(2) In Section 6.6, the words “twenty percent (20%)” shall be deleted and the words “fifty percent (50%)” shall be substituted in their place, and the words “thirty-three percent (33%)” shall be deleted and the words “fifty percent (50%)” shall be substituted in their place.

1.44 “First Commercial Sale” shall mean, with respect to each Product, the first sale for use or consumption by the general public of such Product in a country after required Approval has been granted by the applicable regulatory authority of such country.

1.45 “First Product” shall have the meaning set forth in Section 1.77 hereof.

1.46 “GAAP” shall mean the current United States generally accepted accounting principles, consistently applied.

1.47 “Gross Sales” shall mean, for any period, on a cash basis (a) for any arm’s length transaction in which Products are sold separately by Alimera or its Affiliates to a Third Party, the gross invoice price for Products in such transactions, and (b) for all other transactions (i.e., other than those described in subsection (a)) in which Products are sold, used or otherwise disposed of by Alimera

 

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

 

10

 


or its Affiliates (including in barter or similar transactions, or transactions that are not at arm’s length to a Third Party, or transactions in which Products are not sold separately, but not including the provision of Products intended for use solely as samples), the total imputed sales price for Products in such transactions, using as the imputed sales price the weighted average gross invoice price for Products under subsection (a) during the preceding calendar quarter or, if there have been no Gross Sales under subsection (a) in the preceding quarter, using a reasonable imputed price to be determined at the time by the parties. For purposes of this Section 1.47, “sold separately” shall mean sold, solely for monetary consideration, on a stand-alone basis (i.e., with a selling price independent of any other product) for not less than arm’s length value.

1.48 “Improvements” shall mean any and all Inventions, enhancements, derivatives, new uses, developments, techniques, materials, compounds, products, designs, processes or other technology or intellectual property, whether or not patentable and all Patent Rights and other intellectual property rights in any of the foregoing.

1.49 “IND” shall mean the Investigational New Drug Application filed with FDA or a similar application filed with an applicable regulatory authority outside of the United States.

1.50 “Invention” shall mean ideas, information, Know-How, data, research results, writings, inventions, discoveries, modifications, improvements and other technology (including, but not limited to, any proprietary biological or other materials, compounds or reagents and computer software), whether or not patentable or copyrightable.

1.51 Intentionally omitted.

1.52 “Know-How” shall mean unpatented information, whether or not patentable, including, but not limited to, technical information, processes, formulae, trade secrets, materials, designs, drawings and data.

1.53 “Majority Time Individuals” shall have the meaning set forth in Section 1.36.

1.54 Manufacturing Costs shall mean:

(A) with respect to Product manufactured by a Third Party, a Party’s cost of procuring such Product on an arms’ length basis; or

(B) with respect to Product manufactured by a Party or one of its Affiliates, (1) Direct Costs incurred, on a cash basis, by such Party or one of its Affiliates to manufacture such Product, including Direct Costs of purchasing, inspection, quality assurance, quality control, storage, scrap and training, and (2) a portion of depreciation, amortization, interest expense, utilities, rent, maintenance and repairs, insurance and other manufacturing overhead (the “Manufacturing Overhead”) allocable to Product as determined by the following formula: the Manufacturing Overhead multiplied by a fraction, the numerator of which is the number of direct labor hours of individuals who spent time on the production of Product at a plant at which Product is manufactured, and the denominator of which is the number of direct labor hours devoted to the production of all products at such plant when the plant is operating at full capacity, provided that Manufacturing Costs shall exclude costs associated with excess capacity, selling costs (including, without limitation,

 

11

 


marketing, advertising, salaries and commissions), corporate overhead, costs that are otherwise attributed as Direct Development Costs or Direct Commercialization Costs under this Agreement, royalties (earned or paid up) and other amounts payable to Third Parties under any license taken by a Party in connection with the manufacture of the Product, and all amounts spent on research and development;

provided, however, that any amount determined pursuant to clause (B) shall not exceed the amount that a qualified Third Party manufacturer would charge for supplying comparable quantities of the relevant Product in a timely manner on reasonable and customary terms and conditions.

1.55 “Medical Advisory Services” shall mean those health care professionals employed or engaged by a Party with sufficient medical or other pertinent health care experience to engage in in-depth dialogues with physicians regarding medical issues associated with a Product.

1.55A “Medidur FA” shall mean the product being developed as of the Amendment Effective Date under IND #72056.

1.56 “Milestone Payments” shall have the meaning set forth in Section 6.2 hereof.

1.57 “NDA” shall mean a new drug application or product license application or its equivalent filed with and accepted by the FDA after completion of human clinical trials to obtain marketing approval for a Product, or any comparable application filed with and accepted by the regulatory authorities of a country other than the United States, including, where applicable, any applications for governmental pricing and marketing approval.

1.58 “Net Profits” or “Net Losses” shall mean, for a particular calendar quarter, the Net Sales for a Product in a country minus the Direct Commercialization Costs for such Product in that country. For the avoidance of doubt, Net Profits shall be calculated on a Product-by-Product and calendar quarter-by-quarter basis. To the extent Net Sales exceed Direct Commercialization Costs for the relevant calendar quarter, such amount of difference shall be deemed “Net Profits,” and to the extent Direct Commercialization Costs exceed Net Sales for the relevant calendar quarter, such amount of difference shall be deemed “Net Losses.” For clarification, with respect to calculating Net Profits or Net Losses for any unit of Product, the Manufacturing Cost incurred to manufacture such unit shall be deemed to be incurred in the country and quarter in which such unit is sold.

1.59 “Net Profits Payment” shall have the meaning set forth in Section 6.5.1(b) hereof.

1.60 “Net Sales” shall mean, with regard to a Product, on a cash basis, for any period, Gross Sales less the following reasonable and customary deductions:

(a) normal and customary trade, cash and other discounts, allowances and credits allowed and actually taken directly with respect to sales of the Product;

(b) credits or allowances actually granted for damaged goods or returns or rejections of the Product;

 

12

 


(c) taxes or other governmental charges imposed directly on the sales of Products, including value added taxes or other similar governmental charges, but not including any tax levied with respect to income;

(d) freight, postage, shipping, and insurance charges; and

(e) charge back payments and government rebates allowed and taken.

1.61 “Non-NDA Trial” shall mean any clinical trial, or part of a clinical trial, of a Product that is not designed or required to procure data necessary for the acceptance of filing of an NDA. Non-NDA Trials may be conducted before or after the filing of an NDA, before Approval or at any time after Approval. Non-NDA Trials shall specifically not include (that is, costs associated with such trials may be deemed Direct Development Costs) any (i) clinical trials designed to obtain favorable labeling at the time of initial Approval, (ii) post-Approval or post-marketing trials required by the FDA or other regulatory authority in granting a conditional Approval, or (iii) trials required to obtain Approval for pediatric use of a Product, whether such trials are prior or subsequent to the filing of an NDA or Approval.

1.62 Intentionally omitted.

1.63 “Option Compound” shall mean a compound, other than a compound that is a corticosteroid, that (i) Alimera has a right to use and (ii) is selected by Alimera under an Alimera Compound Option set forth in Section 5.8; provided, however, that Option Compound shall not include any compound that is included in a license or option by CDS to a Third Party, or is included in a term sheet with a Third Party, as of the date on which Alimera notifies CDS under Section 5.8 that Alimera wishes to exercise an Alimera Compound Option with regard to such compound. For the avoidance of doubt, a “compound,” as used herein, shall be a specific compound and shall not be a category or class of compounds.

1.64 “Option Product” shall mean (i) a product that meets the definition of “Product” in Section 1.77, except that the term “Option Compound” shall be substituted in place of “corticosteroid,” and (ii) clause (B)(2) and the third sentence of Section 1.77 shall be omitted.

1.65 “Option Term” shall mean the period commencing on the Effective Date and expiring on the earliest of (i) [*] months after the Effective Date; (ii) the date on which [*]; and (iii) Alimera’s exercise of all [*] Alimera Compound Options under Section 5.8.

1.65A “Original Agreement” shall have the meaning set forth in the recitals.

1.66 Intentionally omitted.

1.67 “Party” shall mean CDS or Alimera.

 

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

 

13

 


1.68 “Patent Rights” shall mean any United States or foreign patent or patent applications, any patents issuing from such patent applications, and any continuations, continuations-in-part to the extent specifically directed to subject matter specifically described in such patent applications, divisionals, renewals, reexaminations, reissues, extensions or provisional applications of any of the foregoing and any corresponding patent, patent application, utility model, inventor certificate, registration or the like in any country of the world with respect to the foregoing.

1.69 “Permitted Subcontractor” shall mean a Third Party or an Affiliate that has been awarded a subcontract with one Party in accordance with Section 3.7 hereof.

1.70 “Phase I Clinical Trial” shall mean a clinical trial as defined in 21 C.F.R. 312.21(a), as may be amended from time to time, or any foreign equivalent thereto.

1.71 Intentionally omitted.

1.72 “Phase II Clinical Trial” shall mean a clinical trial as defined in 21 C.F.R. 312.21(b), as may be amended from time to time, or any foreign equivalent thereto.

1.73 “Phase III Clinical Trial” shall mean a clinical trial as defined in 21 C.F.R. 312.21(c), as may be amended from time to time, or any foreign equivalent thereto.

1.74 “Pre-Existing Clinical IP” shall mean [*].

1.75 “Primary Contact Person” shall have the meaning set forth in Section 3.4.

1.76 “Prime” shall have the meaning set forth in Section 6.5.1(b).

1.77 “Product” shall mean a drug delivery device that meets all of the following criteria: (A) it has a core within a polymer layer that contains a drug in a form other than a CODRUG™ and no other active ingredient, where the core does not include a CODRUG™, (B) it is Approved or designed to be Approved (1) to deliver a corticosteroid and no other active ingredient by implantation, injection, or other direct delivery method to the posterior portion of the eye, or (2) to treat DME by delivering a compound or formulation by implantation, injection, or other direct delivery method other than through an incision smaller than that required for a 25 gauge needle, (C) it does not fall under the definition of Excluded Product, and (D) it is Approved or designed to be Approved for a particular indication in a particular country. For clarification, eye drops or other topical administration and tablets or other oral administration shall not be deemed to be direct delivery to the posterior portion of the eye. For example, “Product” shall specifically include a drug delivery device that meets all of the following criteria (such product sometimes referred to as the “First Product”): (1) consists of [*]; (2) is Approved or designed to be Approved to be administered [*]; (3) is Approved or designed to be

 

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

 

14

 


Approved [*]; and (4) is Approved or designed to be Approved for a particular indication in a particular country. For clarification, with regard to the same drug delivery device described above, each indication in each country shall be a separate Product. By way of non-limiting examples, with regard to a particular drug delivery device X, (i) X for DME and X for age-related macular degeneration shall be two different Products, and (ii) X for DME in the United States and X for DME in Japan shall be two different Products. The Parties acknowledge that Medidur FA is a First Product.

1.78 “Profitability Date” shall mean, with respect to each Product, the first day of the first calendar quarter in which Net Profits are realized for such Product.

1.79 “Recall” shall mean any recall of a product or any related actions (e.g., market withdrawal and stock recovery). For avoidance of doubt, Recall includes recall of product packaging.

1.80 “Right of Access to Clinical IP” shall mean the right to reference, cross-reference, review, have access to, incorporate and use Clinical IP in any regulatory applications or filings, any patent filings, or for any research or development purpose.

1.81 “Selling Expenses” shall mean Direct Costs incurred, on a cash basis, by Alimera for the sales force who are employees of Alimera or its Affiliates, all only pursuant to the Commercialization Budget; provided, however, that if a portion of time of Alimera Majority Time Individuals involved in Detailing Products is devoted to Detailing products other than Products, then only the following percentages of the Alimera Majority Time Individuals’ time spent in Detailing shall be Direct Commercialization Costs:

(a) [*] if the Product is carried in the sole Detail position, in which the Product is the only product presented during a Detail and the key Product attributes are verbally presented in a presentation delivered during the Detail by Alimera’s or its Affiliates’ sales representative;

(b) [*] if the Product is carried in the primary Detail position, in which key Product attributes are verbally presented in the first position during a Detail, where the Product is given primary emphasis (i.e., an emphasis that is more important than the emphasis given to any other product presented), and where no more than three products are presented during such Detail;

(c) [*] if the Product is carried in the secondary Detail position, in which key Product attributes are presented in the second position during a Detail, where the Product is given significant but not primary emphasis, and where no more than three products are presented during such Detail;

 

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

 

15

 


(d) [*] if the Product is carried in the tertiary Detail position, in which key Product attributes are presented in the third position during a Detail, where the Product is given some emphasis, and where three products are presented during such Detail;

provided that (1) if more than one Product is the subject of a Detail, the foregoing percentages shall be cumulative, not to exceed 100% (e.g., if one Product is carried in the primary Detail position and another Product is carried in the secondary Detail position, then [*] of the sales force time shall be a Direct Commercialization Cost with respect to the first Product and [*] shall be a Direct Commercialization Cost with respect to the second Product), and (2) if there are more than three products presented in a Detail, the percentages specified in (b)-(d) above shall be multiplied by a fraction, the numerator of which is three and the denominator of which is the number of products presented in that Detail (e.g., if a Product is carried in the secondary Detail position and there are four products presented during such Detail, then [*] is multiplied by  3 / 4 and [*] of the sales force time shall be a Direct Commercialization Cost with respect to that Product). For clarification, the costs of Majority Time Individuals shall be determined according to the amount of Majority Time Individuals’ time actually spent on Detailing multiplied by the applicable percentage as specified in this Section 1.81 above. For example, if a Majority Time Individual spends twenty-five (25) hours on Detailing, in which Products are carried in the primary Detail positions, then Direct Commercialization Costs attributable to such Detailing shall be the Direct Costs of 25 hours multiplied by [*] (as may be further adjusted as specified above). For further clarification, Selling Expenses relating to a Product may be incurred prior to First Commercial Sale of such Product (e.g., for sales force training); in such event, the percentages referred to in this Section 1.81 initially shall be based on the Detail position for the relevant Product contemplated in the Commercialization Budget. For example, if the Product is projected in the Commercialization Budget to be the sole product Detailed by the sales force, then initially [*] of the Direct Costs associated with the sales force shall be allocated as Selling Expenses. In the event that the actual Detail position for a Product differs from that projected in the Commercialization Budget, then the amount of the Direct Costs that are included as Direct Commercialization Costs shall be adjusted subsequently to reflect the actual Detail position.

1.82 “Term” shall have the meaning set forth in Section 11.1.

1.83 “Territory” shall mean all countries and territories worldwide.

1.84 “Third Party” shall mean any person or entity other than CDS, Alimera or their respective Affiliates.

1.85 “UKRF” shall mean the University of Kentucky Research Foundation.

1.86 “UKRF Costs” shall mean all royalties, milestones and other fees due to UKRF related to a Product pursuant to the UKRF Licenses.

 

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

 

16

 


1.87 “UKRF Licenses” shall mean the licenses set forth in Exhibit 1.87 , as may be amended from time to time consistent with Section 7.9, full and complete copies of which agreements in effect as of the Effective Date have been provided to Alimera.

1.88 “Valid Claim” shall mean a claim of an issued and unexpired patent, or a claim of a pending patent application, which has not been withdrawn, cancelled, abandoned, disclaimed, or held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal.

ARTICLE 2 Intentionally omitted

ARTICLE 3 DEVELOPMENT ACTIVITIES

3.1 General . Subject to Sections 3.1.1 and 3.1.2 below, (a) CDS and Alimera shall undertake development activities for the Products in the Collaboration Field in accordance with this Agreement and (b) during the course of performing such activities, CDS and Alimera shall communicate regularly and shall assume certain rights and responsibilities for the development of the Products in the Collaboration Field in accordance with this Agreement.

3.1.1. Limitation on CDS Development . Notwithstanding any other provision in this Agreement to the contrary (including any provision of Article 2 or 3) and except as the Parties mutually agree in writing, CDS will have no obligation relating to the development of (a) Medidur FA after December 31, 2009 or (b) any Product other than Medidur FA at any time on or after the Amendment Effective Date.

3.1.2. CDS Development Responsibilities and Development Payments . Subject to Section 3.1.1 and this Section 3.1.2, CDS shall be responsible for the performance of only the following development activities: (a) providing clinical supply of Medidur FA as necessary for: (i) the FAME trial (i.e., the fluocinolone acetonide in macular edema trial) ongoing as of the Amendment Effective Date to the extent set forth in protocol C-01-05-001 under IND # 72056, (ii) the PK trial ongoing as of the Amendment Effective Date to the extent set forth in protocol C-01-06-002 under IND # 72056, (iii) an upcoming wet AMD trial for up to thirty (30) patients, (iv) an upcoming vein occlusion trial for up to thirty (30) patients, and (v) one additional marketing support trial, similar to the wet AMD and vein occlusion trials, for up to thirty (30) patients; (b) with respect to Medidur FA, performing the support expressly set forth on Exhibit 3.1.2A hereto for: (i) stability studies for clinical supply of Medidur FA, and (ii) ongoing preclinical work; and (c) performing the technology transfer activities with respect to Medidur FA set forth in Section 3.11. CDS will be reimbursed by Alimera for the costs associated with CDS Development Activities pursuant to this Section 3.1.2, and such payments shall be deemed Direct Development Costs, provided that all such reimbursed costs associated with the wet AMD trial, the vein occlusion trial and the additional marketing support trial shall be deemed Direct Commercialization Costs to the extent such trials are Non-NDA Trials.

CDS Development Budget . Attached hereto as Exhibit 3.1.2B as of the Amendment Effective Date is CDS’ initial budget relating to CDS Development Activities (the “ CDS Development Budget ”). CDS shall from time to time provide to Alimera an updated written budget relating to CDS Development Activities promptly after CDS becomes aware of any discrepancy between the cost of

 

17

 


performing the CDS Development Activities and the amount included in the current CDS Development Budget, which updated budget will become the new “CDS Development Budget” hereunder following good faith discussions and agreement by the Parties in writing on the content thereof.

CDS Reporting and Reimbursement . During the course of the CDS Development Activities as described in this Section 3.1.2, within fifteen (15) calendar days after the end of each calendar month, CDS shall report in writing to Alimera a detailed itemization (including copies of any third party invoices) of the actual costs incurred by CDS in the preceding calendar month. Alimera shall reimburse CDS the actual costs on a monthly basis as follows: to the extent CDS incurred such costs in a calendar month that are within (and do not exceed) the costs in the applicable CDS Development Budget, CDS shall issue an invoice to Alimera for the full amount of such costs incurred and Alimera shall pay to CDS the amount of such invoice (the “ Development Payment ”) within thirty (30) calendar days after delivery of the invoice.

Non-Payment by Alimera . In the event that (i) Alimera fails to make a timely payment of all or a portion of any of its Development Payments and (ii) Alimera fails to pay all such payments under this Agreement within thirty (30) days after receiving written notice from CDS of such outstanding payments (provided that Alimera has a one-time right to use sixty (60) days to cure hereunder), then, automatically and without further action by CDS or Alimera, the Fifty/Fifty Amendments shall be deemed to have been made, which amendments shall apply to all payments due or paid thereafter. The foregoing states the entire liability of Alimera with respect to its failure to make a timely payment of all or a portion of any of its Development Payments (but will not limit Alimera’s liability for any failure to pay CDS Net Profits payments, which is addressed in Section 6.5.1(c)(I)).

3.1.3. Alimera Development Responsibilities . Alimera shall use Commercially Reasonable Efforts to develop the First Product for at least one indication in the Collaboration Field. Before January 31 st of each calendar year, Alimera shall provide CDS with a written status update of its Alimera Development Activities. Alimera shall have sole decision-making authority with respect to the development of Products, consistent with its other obligations under this Agreement.

3.2 Regulatory Approvals.

3.2.1. Regulatory Filings . Unless otherwise agreed in writing by the Parties, Alimera shall be responsible for all U.S. and non-U.S. regulatory matters, including filing an IND and NDA for the First Product, provided that no regulatory filings by Alimera shall include any Pre-Existing Clinical IP. Alimera shall be responsible for obtaining Approvals and for subsequent maintenance of Approvals. For all regulatory filings made in the name of Alimera, Alimera shall have the sole authority and responsibility, for submitting supplements, communications, annual reports, adverse event reports, manufacturing changes, supplier designations and other related filings to, and for communicating with, the FDA and other regulatory authorities. Alimera shall provide CDS with copies of all substantive submissions to (which may be in draft form), and all correspondences from, the FDA or other regulatory authorities which relate to Products.

 

18

 


3.2.2. Manufacture-related Activities . Alimera shall be responsible for preparing and submitting all documentation to regulatory authorities regarding the manufacture of the Product for commercial sale necessary to obtain Approvals for such Product. Alimera shall be responsible for all activities related to pre-Approval inspections of Alimera’s (or its subcontractor’s) manufacturing facility. Alimera shall have the right to inspect and audit CDS’ manufacturing facility and related records and its operations, in each case solely to the extent related to Medidur FA, upon reasonable notice. Any information obtained by Alimera during such visits shall be treated as Confidential Information in accordance with Article 8 of this Agreement.

3.2.3. Documentation . Each Party shall maintain all records, including, but not limited to, batch records and supporting documentation required by the FDA and other applicable regulatory authorities with respect to each Product for the periods of time required by such authorities. Alimera shall provide a copy of all such records to CDS within ten (10) Business Days of reasonable request by CDS. Within ninety (90) days after the Amendment Effective Date, CDS shall provide a copy of all such records that relate to Medidur FA to Alimera (to the extent such records have not previously been provided by CDS to Alimera). In addition, within thirty (30) days after the end of each calendar quarter following the Amendment Effective Date, CDS shall provide to Alimera a copy of all such records that relate to Medidur FA and were generated during such calendar quarter. Without limiting any other provision of this Agreement, upon at least ten (10) days prior written notice, during regular business hours, each Party shall provide the other Party with reasonable access to documents and other materials Controlled by the other Party that are useful in the regulatory filings and maintenance of Approvals for Medidur FA in the Territory.

3.2.4. Reporting . Each Party shall use Commercially Reasonable Efforts to immediately provide notice to the other Party (and shall in any event provide such notice within five (5) days) of: (a) discovery by such Party of any event that triggers a filing requirement with FDA or other regulatory authorities with respect to any Product; and (b) any requirements that FDA may impose with respect to the Approval (including, but not limited to, additional clinical trials) and all FDA inquiries requiring a response with respect to any Product.

3.2.5. Meetings . In connection with Sections 3.2.1 through 3.2.4 above, Alimera shall provide CDS with notice of all meetings, conferences, and discussions (including, but not limited to, advisory committee meetings and any other meeting of experts convened by FDA or other regulatory authorities concerning any topic relevant to Medidur FA) scheduled with FDA or such other regulatory authorities concerning any regulatory matters relating to the Product within five (5) days after Alimera receives notice of the scheduling of such meetings, conferences, or discussions.

3.3 Performance .

3.3.1. Commercially Reasonable Efforts . Subject to Section 3.1.1 and 3.1.2, each Party shall use Commercially Reasonable Efforts to conduct all development activities and responsibilities assigned to it under this Agreement.

 

19

 


3.3.2. Intentionally omitted.

3.4 Primary Contact Persons . As of the Amendment Effective Date, CDS has designated [*] as CDS’ primary contact person and Alimera has designated [*] as Alimera’s primary contact person (each, a “ Primary Contact Person ”). The Primary Contact Persons shall be responsible for the day-to-day interactions between the Parties related to Development Activities and oversight of the day-to-day operations of these activities. The Primary Contact Persons shall attempt to resolve any disputes that arise during the course of performing such activities. If the Primary Contact Persons cannot resolve any such dispute within thirty (30) days (or such longer reasonable period of time as they may agree) after their initial discussion of such issue, the dispute shall be resolved in accordance with Section 12.7. Each Party may change its Primary Contact Person upon written notice to the other Party.

3.5 Availability of Employees . Each Party agrees to make its employees involved in the conduct of the Development Activities related to Medidur FA reasonably available upon reasonable advance notice and during business hours at their respective places of employment to consult with the other Party on issues related to Medidur FA, including, but not limited to, regulatory, scientific, technical and clinical testing issues, arising under Development Activities and in connection with any request from any regulatory agency.

3.6 Visit of Facilities . Subject to the provisions of Article 8, each Party shall permit the other Party or the representatives of the other Party to visit, upon reasonable notice and at reasonably acceptable times, their respective facilities where the Development Activities are being conducted, and to consult informally, during such visits and by telephone, facsimile and email, with their respective personnel performing work on the Development Activities in connection with Medidur FA. Any information obtained by a Party during such visits shall be treated as Confidential Information in accordance with Article 8 of this Agreement. Each Party shall use Commercially Reasonable Efforts to obtain comparable inspection rights with respect to subcontractors.

3.7 Subcontracts . Subject to the provisions of Article 8 and Section 7.3 hereof, each Party may subcontract portions of the development activities to be performed by it to subcontractors, provided that CDS shall obtain the prior written consent of Alimera to subcontract its development activities, which consent shall not be unreasonably withheld or delayed (each such subcontractor, a “ Permitted Subcontractor ”). Any subcontract entered into pursuant to this Section 3.7 shall be consistent with the terms of this Agreement, including providing for intellectual property ownership as set forth herein and all confidentiality obligations of the Parties.

3.8 Information Sharing . Each Party shall provide the other Party with such information related to the providing Party’s Development Activities as the other Party may reasonably request.

 

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

 

20

 


3.9 Records . The Parties will make available to one another all results of the work conducted pursuant to the Development Activities, will promptly disclose to one another such results to the extent they are material, and shall keep such records as described in this Section 3.9 or elsewhere in this Agreement; provided, however, that each Party shall maintain in confidence, and shall limit its use of, such results and records in confidence in accordance with Article 8 hereof and shall not use such results or records without written consent of the other Party except to the extent provided in Section 5.9 or other provisions of this Agreement. The Parties shall maintain records of the results in sufficient detail and in good scientific manner appropriate for patent purposes and FDA filings and as will properly reflect all work done and results achieved in the performance of the Development Activities (including, but not limited to, all data in the form required to be maintained under any applicable governmental regulations). Such records shall include books, records, reports, research notes, charts, graphs, comments, computations, analyses, recordings, photographs, computer programs and documentation thereof, computer information storage means, samples of materials and other graphic or written data generated in connection with the Development Activities. Each Party hereby grants the other Party the right to inspect and copy such records upon reasonable advance notice by the other Party for purposes of this Agreement.

3.10 Manufacturing for Clinical Supply Requirements . CDS and/or its Permitted Subcontractors shall use Commercially Reasonable Efforts to provide an adequate and timely clinical supply, but limited to such quantities and such type and specification as set forth in Section 3.1.2 and all in accordance with GMP and/or ISO standards, to the extent applicable for clinical trials in the relevant country, and other applicable laws and regulations. The Manufacturing Costs for such supply shall be reimbursed by Alimera in accordance with Section 3.1.2 and shall be Direct Development Costs (except that the Manufacturing Costs associated with the wet AMD trial, the vein occlusion trial and the additional marketing support trial shall be deemed Direct Commercialization Costs to the extent such trials are Non-NDA Trials). All Clinical Supply Requirements (beyond those listed in Section 3.1.2) will be Alimera’s sole responsibility.

3.11 Technology Transfer by CDS . Upon the earlier of: (i) written request by Alimera to CDS and (ii) [*] prior to [*], CDS and/or its Permitted Subcontractors shall be responsible for providing to Alimera all information, support and materials that are in each case in CDS’ Control and reasonably necessary to enable Alimera and/or its subcontractors to manufacture and perform quality testing on Medidur FA to satisfy Commercial Supply Requirements, all to the extent set forth in the CDS Development Budget and reimbursed pursuant to Section 3.1.2. CDS and/or its Permitted Subcontractors shall be responsible for the following activities in association therewith (to the extent set forth in the CDS Development Budget and any costs of which will be reimbursed by Alimera in accordance with Section 3.1.2): (a) assist with technology transfer to commercial manufacture site, (b) assist with manufacturing scale-up and validation activities, and (c) transfer analytical methods to commercial manufacture site for stability monitoring. In addition, within ninety (90) days after the Amendment Effective Date, CDS shall provide to Alimera a Pharmaceutical Development

 

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

 

21

 


Report, the form and content of which should follow the ICH Guidance documents Q8 Pharmaceutical Development (dated May 19, 2006) and draft Q8(R1) Pharmaceutical Development Revision 1 (dated January 10, 2008). Within thirty (30) days after receipt of such report, Alimera shall notify CDS in writing whether such report is accepted or rejected (provided that any rejection must be reasonable). If Alimera notifies CDS of its acceptance or fails to notify CDS of its reasonable rejection within the thirty (30) day time period, then such report is deemed to be accepted. If Alimera reasonably rejects the report, then it shall notify CDS in writing of its reasons, with reasonable specificity, for the rejection, and CDS shall use commercially reasonable efforts to revise the report to address such reasons within ten (10) Business Days following receipt of such rejection notice and reasons. CDS shall submit the revised report to Alimera for another review in accordance with the acceptance procedures and timeline specified above. Alimera shall have primary responsibility, with reasonable input and assistance from CDS, for the preparation of the Chemistry, Manufacturing and Controls (the “ CMC ”) section of Alimera’s IND and NDA filings. Technology transfer shall be effected in accordance with GMP and ISO guidelines, to the extent applicable for Commercialization in the relevant country.

ARTICLE 4 COMMERCIALIZATION

4.1 Commercialization of Product(s) in the Collaboration Field . Alimera is granted a license under this Agreement to market, distribute and/or sell any Product in the Collaboration Field in the Territory, including, but not limited to, the right to conduct marketing, reimbursement (e.g., seeking and maintaining pricing and reimbursement approvals from Third Party payors), sales and distribution activities. Alimera may subcontract with any Affiliate or Third Party to perform any of the foregoing activities in accordance with Section 5.3. Alimera shall have sole decision-making authority with respect to the Commercialization of Products, consistent with its other obligations under this Agreement.

4.2 Commercialization Budget . Alimera shall have sole responsibility for implementing Commercialization based on Alimera’s commercially reasonable expectations of the resources and expenses required to Commercialize each Product in the Territory, taking into account industry standards and the competitive environment in effect from time to time with regard to each Product. Alimera shall prepare a budget (“ Commercialization Budget ”) that shall set forth, on a rolling two (2) year basis, the projected sales and the projected Direct Commercialization Costs broken down on a calendar quarter-by-quarter and Product-by-Product basis. Alimera shall prepare semi-annual updates to the Commercialization Budget prior to June 30 and December 31 of each year in which Alimera has a Commercialization Budget or engages in Commercialization of any Products, and shall provide CDS with copies of such semi-annual updates. Prior to finalizing the initial Commercialization Budget and prior to finalizing each subsequent updated Commercialization Budget due by December 31, Alimera shall arrange for the Parties to have an in-person meeting (or, at CDS’ option, a meeting by telephone, videoconference or other means), during which an executive from Alimera shall present in reasonable detail its planned Commercialization activities and Commercialization Budget for the time period covered in the subject Commercialization Budget and CDS shall have opportunities to ask questions and to present its comments on the applicable Commercialization Budget. It is understood and agreed that Alimera shall have sole decision-making authority with respect to the Commercialization Budget, consistent with its other obligations under this Agreement. Alimera shall provide an initial draft Commercialization Budget to CDS on the Amendment Effective Date.

 

22

 


4.3 Diligence . Alimera shall use Commercially Reasonable Efforts to Commercialize the First Product for at least one indication in the Collaboration Field in [*] (collectively, the “ Major Markets ”) and in all countries outside the Major Markets, except for any country outside the Major Markets as to which Alimera has made an election pursuant to Section 4.3.9. For purposes of this Section 4.3 (including Subsections 4.3.1- 4.3.9), the term “Alimera” shall include Alimera and any of its Affiliates, sublicensees and subcontractors. Without limiting the foregoing, Alimera agrees to the following specific obligations:

4.3.1. Alimera shall effect a First Commercial Sale in the United States of the first First Product to receive Approval in the United States (the “ Alimera First Product ”) no later than [*] after obtaining such Approval. Alimera’s nonperformance of an obligation in this Section 4.3.1 shall be excused to the extent directly attributable to a disruption in Commercial Supply Requirements, but only to the extent that such disruption and the impact thereof is outside the control of Alimera.

4.3.2. With respect to Commercialization of the Alimera First Product, Alimera shall expend not less than [*] in Direct Commercialization Costs (excluding Manufacturing Costs) on or before [*], provided that if Alimera is making Commercialization expenditures substantially in accordance with a Commercialization Budget designed to provide for such level of expenditures and the FDA provides Approval sooner than reasonably contemplated by the Commercialization Budget, then the failure to spend at least [*] in Direct Commercialization Costs (excluding Manufacturing Costs) on or before [*] shall be excused.

4.3.3. With respect to Commercialization of the Alimera First Product, Alimera shall expend not less than [*] in Direct Commercialization Costs (excluding Manufacturing Costs, but including expenditures referred to in Section 4.3.2) on or before [*].

4.3.4. With respect to Commercialization of the Alimera First Product, Alimera shall expend not less than [*] in Direct Commercialization Costs (excluding Manufacturing Costs) between [*] and [*].

4.3.5. Alimera shall cause Gross Sales of the Alimera First Products in the United States during the [*] period referred to in Section 4.3.4 to be at least [*] more than Gross Sales of the Alimera First Products in the United States during the immediately preceding [*] period. Alimera’s nonperformance of an obligation in this Section 4.3.5 shall be excused to the extent directly attributable to (1) one or more of the following events, but only to the extent that such event is outside the control of Alimera: a breach of this Agreement by CDS, a disruption in Commercial Supply Requirements, or a Product Recall, or (2) one or more of the following events, but only to the extent that such event materially and adversely affects the market for the First Product: FDA action

 

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

 

23

 


or regulatory guidance affecting Product, a change in reimbursement rates or policies relating to Product, or the introduction of one or more competitive products or services that provide for superior dosing, safety or efficacy.

4.3.6. If Alimera fails to meet any spending obligation set forth in Sections 4.3.2, 4.3.3 or 4.3.4 and such nonperformance is not excused, Alimera may cure such failure by paying to CDS an amount equal to [*]. Alimera’s right to cure under this Section 4.3.6 shall terminate upon a Change of Control of Alimera.

4.3.7. If Alimera fails to achieve the Gross Sales obligation set forth in Section 4.3.5, Alimera may cure such failure by paying to CDS an amount equal to [*] (the “ Extrapolated Net Profits ”). For purposes of this Section 4.3.7, the Extrapolated Net Profits for the [*] period referred to in Section 4.3.4 shall be determined by the following formula: [*].

4.3.8. Non-Performance .

(a) In the event the Fifty/Fifty Amendments have not previously been made in accordance with Sections 3.1.2, 4.3.8(a), 4.4, 6.2B or 6.5.1(c)(II),if Alimera fails to meet any of its obligations under subsections 4.3.1 – 4.3.5 and does not cure such failure in accordance with this Agreement within thirty (30) days of receiving a written notice from CDS requesting Alimera to cure such failure (provided that Alimera has a one-time right to use sixty (60) days to cure hereunder), then, automatically and without further action by CDS or Alimera, the Fifty/Fifty Amendments shall be deemed to have been made, which amendments shall apply to all payments due or paid thereafter.

(b) In the event the Fifty/Fifty Amendments have previously been made in accordance with Sections 3.1.2, 4.3.8(a), 4.4, 6.2B or 6.5.1(c)(II), if Alimera fails to meet any of its obligations under subsections 4.3.1 – 4.3.5 and does not cure such failure in accordance with this Agreement within thirty (30) days of receiving a written notice from CDS requesting Alimera to cure such failure (provided that Alimera has a one-time right to use sixty (60) days to cure hereunder), then CDS may choose one of the following two options: (a) terminate this Agreement, or (b) terminate this Agreement only with respect to the Alimera First Product. In the event of termination pursuant to this Section 4.3.8, Alimera shall not, for a period of [*] from the date of such termination, Develop or Commercialize, or license or otherwise assist an Affiliate or a Third Party to Develop or Commercialize, any product that is Approved or designed to be Approved (1) to [*] or (2) to deliver a [*]. For purposes of this Section 4.3.8, the term “Develop” shall mean performance of human clinical trials for a product. In the event of termination of this Agreement with respect to the Alimera First Product, CDS shall no longer be bound by Section 5.1.2(1), (2), (3) or (4) with respect to such Product. After termination pursuant to this Section 4.3.8 and in the event that CDS (i) makes a First Commercial Sale of the Alimera First Product in the United

 

[*]-INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED WITH THE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED.

 

24

 


States and (ii) reaches the CDS Profitability Date for the Alimera First Product, CDS shall thereafter pay Alimera [*] of CDS Net Income realized by CDS in the United States with respect to such Product until such time as the sum of all such payments plus the revenues otherwise realized by Alimera with respect to such Product in the United States equal the amount of Direct Development Costs and Direct Commercialization Costs previously incurred, on a cash basis, or reimbursed by Alimera with respect to such Product in the United States; provided, however, that in the event that there are CDS Net Losses in any calendar quarter after the CDS Profitability Date, any payment to Alimera shall be offset by such CDS Net Losses.

4.3.9. For clarification, Alimera may elect not to engage in Commercialization in any country outside the Major Markets. If Alimera determines not to engage in Commercialization of any Product in any country outside the Major Markets, Alimera shall so notify CDS. At any time after receipt of such notice, CDS may by written notice to Alimera, effective upon the giving of such notice, terminate Alimera’s license(s), and rights to Commercialize, in such country. Thereafter CDS may, in its sole discretion, directly or through an Affiliate or Third Party, Commercialize the relevant Product(s) in such country. In the event of such termination with respect to a country, CDS shall no longer


 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more